macular degeneration, macular, diagnosis Research – My Macular Degeneration Journey/Journal

Questions and Answers – FDA Approved Treatment for Advanced Dry AMD/Geographic Atrophy/GA

Questions and Answers – FDA Approved Treatment for Advanced Dry AMD/Geographic Atrophy/GA

You may find a lot of the answers to your questions in this article ‘SYFOVRE for geographic atrophy in macular degeneration’ https://clearsightcorner.com/articles/syfovre-first-treatment-approved-geographic-atrophy-amd

Many of your questions will have to be answered by your eye specialist. A retinal specialist, a specially trained ophthalmologist, will administer the treatments.

Syfovre is pronounced “si-FOV-ree.” Where DO they get these names?

Patient Brochure

This is the patient brochure with some of the answers to your questions. https://syfovre.com/wordpress/wp-content/themes/apellis/pdf/SYFOVRE-Patient-Brochure.pdf

What is ‘geographic atrophy’ that I’m hearing so much about now?

A recent CBS News article and interview has been widely shared alerting many to this new treatment (approved on Feb. 17) so we’re getting a lot of questions. Here is the article and video. You may have heard me talk about my friend Sue who just happens to be the person interviewed in this because she’s been in the phase 3 clinical trial and is currently in the long-term follow-up study.  https://www.cbsnews.com/philadelphia/news/first-and-only-fda-approved-drug-to-treat-advanced-macular-degeneration/

AMD has 3 basic stages: early dry, intermediate dry, and advanced or late AMD. There are 2 types of advanced AMD: wet AMD and geographic atrophy which is the advanced stage of the dry form. There are 2 basic types of GA: outside the fovea (the center of the macula) and inside the fovea. For more information, here’s a good site. https://eyesonga.com/what-is-ga

How do I know if I have it?

It can only be diagnosed by testing done by an eye professional. Ask your eye specialist to tell you whether it is inside or outside of the fovea. In the early stages of GA, you might not be able to see any changes especially if it is outside the fovea.

Who is it NOT for?

It’s not for those with dry AMD at the early or intermediate stages. It’s not for those with other forms of macular degeneration such as Stargardt’s Disease or Myopic Macular Degeneration.

What if I have wet and GA?

In the clinical trials, they did not use the treatment for anyone with both GA and wet AMD in the eye they treated. For that reason, retinal specialists are discussing its use in this case and will make decisions for each individual.

What if I have GA and glaucoma?

If you have glaucoma and are considering Syfovre eye injections, it’s important to let your retinal specialist know about your condition. While it’s possible for people with glaucoma to receive these injections, they need to be monitored closely or have pre-treatment eye drops before their injections.

Eye injections can sometimes cause a temporary increase in eye pressure, which can be harmful to people with advanced glaucoma. This is why it’s important to take steps to prevent any increases in eye pressure before giving the injections. Your doctor may use anti-glaucoma eye drops to lower the pressure in your eyes before giving you the injection to help minimize any risk. Your condition will also be monitored more closely.

Is it only available in the US?

As of February 17, 2023, Syfovre received approval in the United States, according to the company’s press release. The European Medicines Agency is currently reviewing a marketing authorization application for Syfovre, with a decision expected in early 2024. Additionally, a marketing application for Syfovre has been submitted to Health Canada. If you live outside of the United States, Europe, or Canada, please check with your doctor to find out if Syfovre is available in your local market.https://investors.apellis.com/news-releases/news-release-details/fda-approves-syfovretm-pegcetacoplan-injection-first-and-only

What does it do? What does it not do?

It slows the progression of the disease which is measured by the size and rate of growth of what’s called a lesion which is an area of damage of the retina. The word ‘geographic’ comes from how the macula appears when an eye doctor looks at it: it’s like looking at a map where there are islands of damaged retinal cells – the lesion – in a sea of healthy ones.

The lesion starts outside the fovea – the center of the macula. The lesion causes you to have blind or blurry spots outside the very center of your vision. The lesions can progress to inside the fovea where you you will have one or more blind or blurry spots sometimes called scotomas.

It does not improve vision or restore any lost vision.

How well does it work?

Syfovre has been shown in studies to reduce the growth of geographic atrophy lesions more effectively than a sham injection. The treatment’s effects also increased over time.

A sham injection is a procedure used in clinical trials where everyone receives an injection, but some do not receive the drug being tested. The growth rate of the lesion in the treatment group is then compared to that in the sham group to evaluate the effectiveness of the drug.

For the actual results in numbers, you can find them here. You can ask your retinal specialist to help you understand them. https://syfovre.com/about-syfovre/what-is-syfovre/ and https://syfovreecp.com/oaks-and-derby-efficacy

How is it administered?

It is injected into the eye much like the treatments for wet AMD. The eye is disinfected, then a numbing agent is administered, then the injection is given with a very small needle. The eye is rinsed out, and you’d be given instructions about taking care of the eye at home.

It can be given every 25 to 60 days depending on the advice of your retinal specialist. The research showed that monthly treatments worked better than every two months. Also, the longer the treatment, the better the results.

To get the best results, you have to keep getting the treatments as your retinal specialist advises.

What are the possible side effects or risks?

You can find them all at https://syfovre.com/faqs/ and the patient brochure https://syfovre.com/wordpress/wp-content/themes/apellis/pdf/SYFOVRE-Patient-Brochure.pdf

Most common: floaters, eye discomfort, infection (can be treated), blood in the white of the eye (resolves over a period of time), wet AMD (can be treated)

Other possible side effects: eye infection, retinal detachment, temporary increased eye pressure after the injection

I keep hearing that it may cause my GA to become wet AMD. What’s the chance of that and what would happen if it did convert to wet AMD?

First, it’s your retinal specialist who can tell you more about the chance of this for you. Everyone is different so everyone’s risk of this will be different. For example, if you have wet in one eye but not the other, that non-wet eye has a higher risk of becoming wet than if you didn’t have wet AMD at all – even if you don’t have this treatment. In that case, your retinal specialist may not want to treat an eye with GA if you have wet in the other one. Everyone will be monitored closely for signs of this change and treatment for wet AMD will be started.

For the actual numbers, my friend Sue who was in the phase 3 clinical trial, is in the long-term follow-up study, and who was in the CBS News piece, wrote about that in this article ‘Pegcetacoplan Side Effect Hunting.’ https://maculardegeneration.net/living/pegcetacoplan-study and https://syfovreecp.com/safety/

She talks about the risk for those who have a higher risk of developing wet to begin with (above) vs those who do not. Remember, it’s your retinal specialist who is the only one who can evaluate YOUR risk. She talks about how she made her decision to get the treatment by evaluating the risks vs the benefits to her.

How do I decide if it’s worth it for me?

There are risks with anything. It comes down to evaluating the benefits vs the risks for you. It’s your retinal specialist who can best help you with this. Sue wrote ‘What Does Syfovre Mean For You?’ https://maculardegeneration.net/living/thoughts-on-syfovre

What will it cost? Will my insurance pay for it?

Please don’t freak out if you see the ‘cost’ of Syfovre as over $2000. That is the cash price and we don’t think anyone is going to pay that! But for some people, getting the cost covered or getting financial help will take time. This is how the process goes with all new drugs such as the newest treatment for wet AMD Vabysmo. All the cash prices for the wet AMD treatments are about this, except Avastin, but no one that we know of pays it because of insurance and financial programs.

Medicare has been the first insurance to pay with Medicare Advantage plans requiring pre-approval. Commercial insurances are working on it, but it takes time, just as it did with the new treatments for wet AMD. You can appeal to your insurance company which might speed things up.

What if my insurance does NOT pay for it, or I don’t have insurance?

There are several sources of financial help. Your retinal specialist should have someone to help you navigate this.

Apellis Pharmaceuticals, the company who makes it, has a program called Apellis Assist. They’ll help you work with your insurance company if necessary and if eligible, provide financial assistance. This might be the best first source.  https://syfovre.com/resources-for-you/apellisassist/

There’s another program called Good Days which has helped with costs for wet AMD treatments and is expected to help with this. You can check it our here. https://www.mygooddays.org

So this is the only treatment for geographic atrophy – my only option?

It is currently, but there’s a second treatment that completed the 3 phases of clinical trials and is waiting for FDA approval from Iveric Bio called Zimura. Approval is expected in August 2023. You can find out more about that here. https://investors.ivericbio.com/news-releases/news-release-details/iveric-bio-announces-fda-accepts-new-drug-application-and-grants

How do these 2 treatments (Syfovre and Zimura) compare? Should I wait?

You can find that here. You and  your retinal specialist can discuss whether it might be best for you to wait for this treatment.  https://clearsightcorner.com/articles/syfovre-first-treatment-approved-geographic-atrophy-amd

There are MORE treatments at various stages in the pipeline. This recent article (Feb 14 2023) is titled ‘2023: The year of geographic atrophy: A comprehensive look at 87 clinical programs for investigative treatments in retina.’ https://www.retina-specialist.com/article/2023-the-year-of-geographic-atrophy

Why is my retinal specialist not using it?

Some retinal specialists are conservative and are waiting for more information from the long-term study going on and the ‘real world’ data which means how well is working now with patients that it’s been approved.  Sometimes treatments go through clinical trials and are approved, but when they used with a winder population, problems can arise.

That’s a great question to ask your retinal specialist. You might find this article written by an authority in the field interesting as Charles Wykoff, MD, PhD, Director of Clinical Research, Retina Consultants of Texas, talks about how he is approaching it with his patients. https://www.hcplive.com/view/charles-wykoff-md-significance-pegcetacoplan-approval-geographic-atrophy?

Why aren’t researchers trying to stop the disease before it gets to an advanced stage?

That’s a great question especially since -85-90% of those with AMD have early or intermediate AMD. AMD is a complicated disease with many factors and no one cause. Therefore, researchers are working in many areas including the prevention of it and stopping or slowing it at the early and intermediate stages. In many complicated diseases, we see research in the advanced stages because that’s where there can be the most damage. That’s why we have had so many treatments for wet AMD for 20 years: most of the damage to central vision is from untreated wet AMD. It’s the same with advanced dry AMD: the disease process needs to be slowed to prevent central vision loss.

Here’s an article with 87 research studies for various stages and types of retinal disease. https://www.retina-specialist.com/article/2023-the-year-of-geographic-atrophy

Many of your questions will have to be answered by your eye specialist. It is a retinal specialist, a specially trained ophthalmologist, who would be giving the treatments.

This is the patient brochure with some of the answers to your questions. https://syfovre.com/wordpress/wp-content/themes/apellis/pdf/SYFOVRE-Patient-Brochure.pdf

Created April 20th, 2023 Linda Chernek Moore, light2sight5153@gmail.com

 

 

Sue – ‘Super Lab Rat’ – Fulfills a Pledge. March 2023

Hi, it’s Sue! Back in 2018 or so, I was celebrating getting into a clinical trial. I vowed I would do whatever I could to become the best, damn “lab rat” that Wills Eye Hospital had ever seen. I was going to be a super lab rat with all sorts of great accomplishments to my credit. [Lin/Linda here: it was actually June 2019 when she wrote about being accepted into the APL-2 clinical trial: Finally a Lab Rat. Considering how active her life is, I’m not at all surprised she can’t keep the dates straight! ::grin::]

Spokes Rat

Well, I don’t know if I have actually been good enough to be considered a super lab rat but today I fulfilled one of my pledges. Today I became a ‘spokes rat’ for the medication they have been shooting into my eye, Syfovre. Yes! If your mind can conceive it, you can achieve it. Positive thinking, folks, positive thinking. [At the end, I’ve listed the pages she’s written about her experience in this clinical trial.]

My friend took me to Wills Eye Hospital in Philadelphia today for my very first – and possibly last! – television interview! How do you like that for a kick in the pants? I was interviewed by the local CBS affiliate and I suspect the anchor person and the cameraman were really sorry they had caught this assignment. I talked their ears off…for about 45 minutes… or more. [It will be uploaded to YouTube. When it is, of course I’ll share it.]

I was anxious; yes. By the time they pare my 45 minute ramble to about 45 second, I will not have much exposure but it was still my FIRST TV APPEARANCE. There are over 1.5 million people in Philly. What if somebody sees me? Gulp.

But more important is this: I wanted to get out the right message. I did not want to talk about what it was like to lose my sight. That was over 7 years ago. People who look to the past with sadness and regret get depressed. I have no time for such things. I wanted to talk about now and the future. I wanted to talk about hope.

When I thanked Dr. Garg for recommending me for this assignment he said he wanted someone with energy and enthusiasm. How can I NOT be enthusiastic? In seven years i have gone from the hopelessness of being told there is no treatment and no cure to the approval of the first treatment for geographic atrophy. And I helped. Sort of.

Syfovre can buy us time. Time to ultimately find the cure for dry age-related degeneration, a disease that some say is of epidemic proportion. Lot of people losing their sight out there but at least they now have hope.

Of course, there are still some hurdles to jump over. One does not manufacture millions of doses of a new drug overnight. Apellis is gearing up even as I type. Also, this is not an inexpensive proposition. It was mentioned that the research staff is thinking about injecting both eyes of us ‘lab rats,’ but they are not sure how to cover the cost. How much will Medicare and other insurance companies cover? These are questions for which the answers are still being formulated.

And future treatments? I am still lobbying hard for stem cells but today I heard gene therapy is looking very promising.

The word is promising. It is related to hope. It is related to a brighter future, if your mind can conceive it, you can achieve it. If I can give a TV interview, just about anything can happen!


Sue’s Series on Syfovre

Lin/Linda: Her first aspiration to be a ‘super lab rat’ was not long after she considers the start of her status as legally blind: February 2016. You can read about that here: In the Beginning.

It was June 2019 she was Finally a Lab Rat. In July of that year, she wrote about her first injection: The Beginning of My Clinical Trial.

In August 2022, before the FDA approved Syfovre and after she was accepted into the long-term follow-up study, she wrote about her ‘Diabolical Plan’ to be accepted into a stem cell clinical trial while she’s still alive: My Diabolical Plan: Stem Cell Transplant for Dry AMD.

She also wrote about the discussions of the studies: Pegcetacoplan Study Cliffhanger.

After the drug was approved, she revised her article from her perspective of being halfway through the 3-year follow-up study:  My Diabolical Plan Revisited March 2023.

She’s also written What Does Syfovre Mean for You?

Who is Sue, and Why Should You Get to Know Her?

Since there’s not a simple answer to that, I recommend that you choose this where I’ve provided an answer.

 

 

First FDA-approved Treatment for Advanced Dry AMD/Geographic Atrophy/GA: Perspective from Sue

Sue has been in the Syfovre research for about 5 years: here’s the timing:

  • 7 years ago, my long-time friend Sue became legally blind from GA.
  • In 2019, she was accepted into the phase 3 clinical trial for what was then called APL-2 from Apellis Pharmaceuticals. It lasted 24 months/2 years.
  • 1-1/2 years ago, she was accepted into the long-term follow-up study that was then mostly called pegcetacoplan. It’s a 36 month3 year study so she’s halfway through it.

If there’s a gap in time, it’s because the trial was shut down for a time because of COVID.

On February 17th, that treatment was approved by the FDA and is not called Syfovre.

She’s written several articles about this, and this is a new one.
Next week she is going to Philadelphia to appear on an ABC-affiliate TV show with one of the researchers from Wills Eye Hospital which is where she was enrolled in the studies. She’s not sure how widely it will be distributed. I’ll keep you posted.

This is her latest article which includes this statement:

“This drug means hope. This drug means no retinal specialist ever again has to tell a patient there is no treatment, no cure [she’s talking about stem cell research here; read her other article in the comments] and they should go home and go quietly blind. No GA patient will need to leave his retina special appointment feeling hopeless. This drug shines a glimmer at the end of the tunnel. We just may get out of this yet.”

What Does Syfovre Mean for You?’ https://maculardegeneration.net/living/thoughts-on-syfovre

Questions and Answers From Her

1. Does she know whether she got the placebo or the treatment in the phase 3 trial?

No. Why not? She’s in the long-term follow-up so she’s still in what’s considered a research study. They don’t reveal the results to individuals till all the date is gathered.

She HAS been getting the treatment (now called Syfovre) every month for almost 1-1/2 year in the long-term follow-up study. In the phase 3 trial, they used her ‘bad’ eye and continue to treat it only. It’s common to do that in research so as not to jeopardize a ‘good’ eye, relatively speaking. While she’s in still in the research, there’s no option to treat the other eye.

2. Can she tell any difference?

The treatment was not shown to improve vision in the clinical trials. She’s had no improvement in visual acuity. She says her visual acuity in both eyes has stayed pretty much the same during these 5 years, but keep in mind that tests of visual acuity are not entirely objective. She admits that they allow her to use her ‘sweet spot’/best area of vision which may have varied over the years. She says she has seen some ‘real world’ decline, but that’s hard to objectify and not uncommon in geographic atrophy. Her visual acuity in her bad eye over the years has ranged between 20-160 to 200; good eye 20-60 to 80. Bottom line is that she is legally blind.

3. If the purpose is to slow down the progression, has it slowed hers?

She doesn’t know…yet. Hopefully at the end of the long-term study (1-12/ more years), they’ll give her the data they gathered from her trial.

4. Does she have any side effects from the injections?

She has them. They’re similar to those of wet AMD because it’s the same concept: ‘intravitreal injection’ means injection into (inter) the vitreous fluid. The injections don’t hurt, she’s not had any bruising/bloody eye, but she does regularly get floaters & air bubbles that resolve in a few hours. She had some episodes where her eye pressure increases, and she only has light perception – lasts only seconds.

Any Other Questions For Her?

I can pass them along. She even said she’d do a Zoom session if there was enough interest.

Her Diabolical Plan

She has a long-range plan. I’ll let her tell you about it. It includes being included in a stem cell trial in the future which would replace damaged RPEs.

If you don’t know the full story of Sue’s journey, I highly recommend that you read it – it’s in the article at the end. Briefly, in July she’ll be 70. She stills work and is extremely active. When I redid her bio as I[‘ve done many times, I came up with this line which might sum it up:

“What she does NOT do is let her geographic atrophy stop her from doing what she wants to do. As she said herself she is persistent and determined.”

You can read or listen to her story here. It’s a 7 minute listen–>
https://mymacularjournal.com/my-diabolical-plan-revisited-march-2023

My Diabolical Plan – Revisited March 2023 – by Sue LaBar Yohey

Some of you may know I can be persistent -very ! -and even manipulative. I get a plan in my head and make the moves to follow it through.

Ever since I was diagnosed as legally blind with geographic atrophy, advanced age-related macular degeneration, in February 2016, I have had a master plan, a DIABOLICAL plan, for recovering my eye sight sometime before I die [Linda here: curious how old she is? At the time of this article, she is 69. She’s determined to live a LONG time. ::smile::]. This plan started with presenting myself as a patient to the esteemed retinologist Dr. Carl Regillo  from Wills Eye Hospital in Philadelphia. I then expressed interest in being in a study. I wanted a clinical trial hopefully involving stem cells.

After what seemed like dozens of trips to Bethlehem, Pennsylvania, my persistence paid off. I was offered a place in phase 3 of a study using a complement factor inhibiter that had been considered to have promise. While initially it seemed as if being offered this study was one step to the left of where I wanted to be, I decided to take it. It was my “in” and I was not guaranteed another opportunity.

As it turned out, I had the honor of being part of the trials that brought forth the first, FDA-approved treatment for geographic atrophy. This is Syfovre from Apellis.

How do I feel about this? While my contribution was small, it is still kind of cool to have been involved in the making of medical history. I feel like the water boy for the Super Bowl or maybe like the ball boy/girl at Wimbledon. Helping to make it happen gives me pride.

So here I am, two steps in the Diabolical Plan successfully behind me. I manipulated getting to see Regillo, I wanted him as a doctor and took steps to make that happen. Regillo almost guaranteed I would be in a study. Funny, although I had no way to determine the outcome of the study, I never doubted the treatment would be approved. Forgive my arrogance, but without its approval, my plan could not progress, and, as far as I am concerned, it IS happening. If my plan was going to work, the treatment had to work first. I never doubted.

Right now, I am half way through a 3-year study in which they are searching for side effects. For me, this study is a place holder in three ways. First of all, it keeps me in front of the doctors running the show. While I cannot go into just any old study, I could go into another study involving Syfovre. When one of those comes along, I will be bouncing up and down on the sidelines. “Put me in, coach. I want to play!”

The other reasons this study is a place holder are these: medical science is not there yet.
Also, Syfovre is not the best we can do.

Second one first: while the Benz Motorwagen was a great innovation in 1886, it was also not at the front of the pack for long. And yes, that really was the first car. I looked it up.) Just like the Benz Motorwagen was replaced by more efficient cars, there will be other, better treatments for GA. My believe is the ultimate “treatment” will be “replacement parts”. Enter stem cells.

They have now learned how to “reverse engineer” blood and skin cells to become induced pluripotent stem cells. Once you have these, they can be “coaxed” and “massaged” into becoming retinal pigment epithelial cells. Remember RPEs are the “servant cells” that keep the photoreceptors alive. Without RPEs there are no photoreceptors and no sight.

According to a panel member on the March 2nd, 2023, webinar ‘Towards a Stem Cell Cure for Blindness,’ lab-grown RPE cells might be available to the general public in about six years. They are moving fast but they are still in phase 1 trials. In other words medical science is not ready for me yet.

Moving on with my thinking, Syfovre will be a way for me, and perhaps millions of others, to buy time. Syfovre slows the deterioration. Current wisdom is that stem cell therapy and RPE replacement stops deterioration. If Apellis wants to sell their drug, they have to prove it will not keep people from eventually benefitting from the superior treatment. Voila! There is my – yet imaginary – next step in my Diabolical Plan. Put me in, coach!

And just a reminder, replacing RPEs will not restore vision. As I have said before, dead is dead and a number of my photoreceptors are dead. However, replacement RPEs will stop my vision from getting worse. They may also improve it slightly, not much, by resuscitating photoreceptors on their last legs.

What about photoreceptor replacement? After all, I do need those replaced to restore my vision. That technology is much further down the road but still getting closer every day. It will get here in time. After all, I have a Diabolic Plan to complete!

Who is Sue and Why Should You Get to Know Her?

The Facebook Group

First, it weren’t for Sue, the Facebook group wouldn’t exist! We’ve been close friends since college which is now a LONG time ago. In June 2015 she was driving, got something in one eye and closed it, and the car in front of her disappeared! You can read about that and how her journey with AMD began here: In the Beginning. In February 2016 when she was told that she was legally blind, she asked me to create a site for her so that she could process what was going on and to hopefully help others. In May 2016 after months of not being able to easily have conversations with followers, I started the Facebook group. The rest, as they say, is history.

Her Journey

After less than a year of learning how to deal with her visual impairment both physically and emotionally, Sue created a ‘normal for her’ life. What is it like? It’s like her life ‘before’ except she does not drive. What she does is travel domestically (sometimes even by herself) and aboard, works as a psychologist, walks her 2 active Labrador Retrievers, attends multiple exercise classes every week, rides her bike safely, takes photographs (some of which have won awards locally), skis in the Winter and rafts in the Summer, goes to social events with her friends and co-workers. She’s also taught courses in the psychological therapy called DBT (Dialectical Behavioral Therapy) that she uses with her clients and used herself in the beginning of her journey.

What she does NOT do is let her geographic atrophy stop her from doing what she wants to do. As she said herself she is persistent and determined.

For quite a few years, she wrote for this site, but it’s now more an archive. She writes for Health Union’s maculardegeneration.net site where you can read her more recent articles. As she wrote, she was in the phase 3 Apellis Pharmaceuticals clinical trial for what was called APL-2 then, was invited to be in the long-term follow-up study where it was called pegcetacoplan which is called Syfovre since it’s approval by the FDA on February 17th. 2023.

When asked what her visual acuity is, she says it’s 20/63 to 20/80 in one eye & between 20/160 and 20/200 in the other. Yes, she has a blind spot in the middle of each eye but has taught herself how to use her ‘sweet spot’ also called a Preferred Retinal Location.

 

 

 

 

Myopic Macular Degeneration: Understanding the Basics

by Frank Chen (see his biography at the end of the article).

The prevalence of myopic macular degeneration is on the rise worldwide, and new research is providing greater insight into this complex condition. As our understanding of the condition continues to evolve rapidly, staying up-to-date on the latest developments is crucial — starting from the fundamentals.

Myopic macular degeneration is a debilitating eye condition that affects millions worldwide, leading to a gradual loss of central vision. Like age-related macular degeneration (AMD), myopic macular degeneration affects the central part of the retina, causing symptoms such as blurry vision, distorted vision, and loss of visual acuity.

However, myopic macular degeneration is primarily associated with high myopia and pathologic myopia, which affect people at a younger age than AMD. In this article, we will discuss the key terms and definitions related to myopic macular degeneration, its causes and prevalence, and the treatment options available to manage the condition.

Understanding the Key Terminology of Myopic Macular Degeneration

Myopic macular degeneration is an eye condition that is becoming better understood through ongoing research. As we learn more, terms and definitions evolve or are added to our understanding of this condition. Here are some important terms to know:

Myopia: This is a common refractive error that causes distant objects to appear blurry. It occurs when the eyeball is too long, or the cornea is too curved, causing light to focus in front of the retina instead of on it.

High myopia is a more severe form of myopia, usually defined as more than -6.00 D in diopters. It is often confused with pathologic myopia, which causes degenerative changes in the back of the eye.
Pathologic myopia occurs when the eye grows too long, leading to changes in the back of the eye. These changes can cause problems such as blurry vision, difficulty seeing in low light, and even vision loss.

Myopic Macular Degeneration (MMD) is also called myopic maculopathy (MM); it is one of the most common types of pathologic myopia. It occurs when the cells responsible for sharp, detailed vision in the eye start to die. And patients gradually lose central vision.

Myopic chorioretinal neovascularization (myopic CNV) is also referred to as myopic macular neovascularization (MNV) in many publications. It happens when abnormally new blood vessels grow under the macula. As blood and fluid leak into the macula, it damages the retina cells, which leads to vision loss.

Causes and Prevalence of Myopic Macular Degeneration

Myopic macular degeneration is a condition that affects the central part of the retina, known as the macula, and causes it to degenerate. This can result in symptoms such as blurry or distorted vision, dark or empty areas in the field of vision, and a gradual loss of visual acuity over time, similar to age-related macular degeneration (AMD).

The exact cause of myopic macular degeneration is unclear, but several factors are believed to contribute to its development. These factors include elongation of the eye, cracks in the retina, and protrusion or bulging of the back part of the eye (myopic conus).

As myopia is becoming increasingly common worldwide, studies found a rise in the prevalence of myopic macular degeneration. It was projected that by 2050, around 50% of the global population could have myopia.

Furthermore, the risk of developing pathologic myopia, which could lead to myopic macular degeneration, increased with higher degrees of myopia. Age was also a significant factor, as individuals with high myopia aged 40 or older had a higher risk of developing pathologic myopia.

Studies showed that pathologic myopia affected approximately 1-3% of Asians and 1% of Caucasians. Pathologic myopia was identified to be the leading cause of irreversible blindness in several Asian countries. While in Western countries, it ranked as the third leading cause of blindness. Both ethnicity and country of origin seemed to play a role.

Treatment for Myopic Chorioretinal Neovascularization (Myopic CNV)

Several treatment options are available that can help slow the progression of myopic chorioretinal neovascularization (myopic CNV) and improve vision. The primary treatment for myopic CNV is anti-VEGF therapy, which includes several different drugs like ranibizumab (Lucentis), aflibercept (Eylea), and conbercept (Lumitin). Although bevacizumab (Avastin) is not FDA-approved for myopic CNV, it may still be used as an off-label treatment due to cost.

In cases where anti-VEGF therapy is not suitable, verteporfin photodynamic therapy (vPDT) may be recommended. However, vPDT didn’t show significant improvement in visual acuity and could damage the retina cells, leading to a worsening of vision instead. Therefore, intravitreal anti-VEGF therapy is considered the standard-of-care treatment for myopic CNV. As with any treatment, there are benefits and risks. Therefore, it is important to discuss treatment options with your healthcare provider to find the most effective and appropriate treatment for your specific situation if you have myopic CNV.

Key Takeaways

In conclusion, myopic macular degeneration is a serious eye condition that affects millions worldwide, leading to a gradual loss of their vision. While it shares similarities with age-related macular degeneration, myopic macular degeneration is primarily associated with high myopia and pathologic myopia, which affect people at a younger age. With the rise in myopia prevalence worldwide, understanding the latest development, starting from the fundamentals, is essential.

Fortunately, there are treatment options available for myopic chorioretinal neovascularization. And it is fueled by ongoing research and innovation, providing hope for a bright future for people living with this condition.

About the Author

Frank Chen is a highly experienced health educator and medical writer with almost two decades of experience in the healthcare and pharmaceutical industries. He holds a Bachelor of Science degree and an MBA, and is also certified in nutritional sciences and medical writing, bringing a broad range of knowledge to his work. Frank is deeply committed to enhancing patient health literacy and promoting better patient outcomes. His passion for helping patients understand their health conditions is evident in his exemplary education work for ocular conditions at clearsightcorner.com.

Frank has collaborated with top medical experts in ophthalmology, diabetes, and cardiovascular fields throughout the years. He has also played vital roles in developing and implementing patient communication or support projects that have had a profound positive impact on the lives of hundreds of thousands of patients across multiple countries.

Article published Feb. 25th, 2023.

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Cosmos and Chaos: My Plan to Have More Good Sight Days!

I have been taught that cosmos is synonymous with order and structure in the Universe. Chaos is the opposite. Everything in the Universe tends to breakdown from order and structure to chaos. I believe this is called entropy. We, as sentient beings, love order and abhor chaos. Where there are no patterns, we invent them. When things are falling apart, we try to build them back up. Chaos in the Universe may eventually be inevitable, but in our puny ways, we try to put up a good fight.

Where did all of THIS come from? This waxing philosophical nonsense does not fit with the topic of vision loss…or does it?

Lin texted me when I was in Zumba Strong. Zumba Strong is a combination of calisthenics, weight lifting, kick boxing and whatever else the instructor wants to throw in. The instructor at our Y is about 26 years younger than I am and takes no prisoners. I fumble along the best I can. WHAT do I think I am doing in that class?

Quite simply, I am fighting the inevitable. I am fighting physical decline and chaos.

Don’t worry. I don’t expect to ‘win’. Someday I will become feeble and pass away. Just not today or not tomorrow either.

We all have our versions of my exercise classes. We eat our vegetables and take our medications. We clean our houses and organize our closets. We do what we can to stave off chaos. That is what we do. We all try to delay the inevitable loss of order in the Universe.

So NOW will I tell you what her text said? Ok. What it said was the group has a member who does not see the point of a drug like APL-2 (Pegcetacoplan), the drug I am getting in the clinical trial. That sort of drug won’t cure AMD. It will only put off the inevitable of “going blind” as the member described it.

I saw this text as I was sweating my sweet patootie off in exercise class. It made me laugh because I immediately saw the parallels. I not only exercise because – being human – I am not a big fan of chaos (no matter what my house looks like!), but also because I like the results. My body is not falling apart as fast as it would without the exercise. I see that as a good thing.

Being more physically capable allows me to enjoy life longer and more fully. Every day of physical health is a day I can savor and not have to worry about. I might not have more days because I am physically active, but I will have more good days. I will have more days I can function and maintain my independence. This is important to me.

I see a drug like APL-2 in the same light as exercise.

A slower deterioration of my vision will allow more good days. More fun. More independence. More of everything that sight allows.

And a final note about the inevitability of “going blind.” Simply put, it ain’t necessarily so. Not only does AMD generally not lead to total blindness, but in this day and age, it might not lead to inevitable, permanent sight loss at all!

You see, when it comes to vision loss – ‘blindness’ – I am not just buying a few, more, good days, I am waiting for the cavalry to come.

I am buying times for the rescue party to be organized. In my mind, unlike death and chaos, blindness is not inevitable.

Of course, I am not just waiting for that rescue party, I have gone out to meet it. Quite frankly, I want to be one of the first ones rescued. That is why, about four years ago, I got into a clinical trial.

You see, I have a plan. It is probably a ten-year plan, maybe longer, but I can wait.

The first phase is over. I completed three years in a phase 3 clinical trial for APL-2. now I am in a long-term trial to check both safety and efficacy over time. The drug has recently been submitted to the FDA and, if approved, there might soon be millions of people slowing the progression of their AMD with its use.

The next part of my plan is the slightly diabolical part. I am betting stem cell replacement for RPEs is coming soon. You cannot have millions of people on a drug that will not allow them to progress to the next level of treatment. You have to check it out. I want to be in that study. And after that, I want to be part of the study that replaces photoreceptors. Science is not there yet, but it will be. Reasonably soon.

To sum up, fighting decay, entropy and chaos is part of being human. We do it everyday, not perhaps, to win in the end, but to delay and survive a little longer. We delay because every moment of good functioning in life is a priceless gift.

And, as Benjamin Franklin said, the only sure things in life are death and taxes. I do not believe blindness should be added to that list.

Even if APL-2 will not stop this condition, it will buy time for the cavalry to get here. My money is on medical science. I believe they will – in time – come through with a real cure.

Happy New Year 2022!

In real time it is Christmas Eve, 2021. Next week at this time we will be ushering in a new year. 2022 will be here and 2021 will be done. Thank God.

I dare say 2021 has stunk! I have lost parts of my life I value. COVID has tried its best to demoralize me and defeat me. Come the end of March, I will have been working from home for two years. We closed the physical office the third week of March 2020. I miss my colleagues. I miss the change of scenery.

My transportation – less than desirable to begin with – has become even more unsatisfactory. We are now “allowed” to grocery shop two days a week. With no spare drivers, they turn into pumpkins at 4:00 pm. They also no longer work Saturdays. I no longer have the option of going to the gym, and the work-outs I do get are on Zoom. While I am glad to at least have those, they do leave a bit to be desired. It seems the only “legitimate” place I can go on transportation is the doctor’s office. Great fun.

While I snuck in a couple of adventures in the fall, more than local travel has been adversely effected as well. I had hoped to see more of the world before I went too terribly blind. How am I going to see the world when the pandemic has me sitting at home?

Although I could go on, I will spare you my pathetic whining. Suffice it to say, 2021 has been pretty stinky and the longer I live in these conditions, the more frustrated I get. The pandemic and pandemic restrictions, while necessary, have dimmed my normally sunny outlook. I am pretty sure many feel the same.

COVID has been limiting our lives and truncating our horizons. Or at least so it seems. And Covid is not the only debacle/ disaster of 2021. But perhaps not all is doom and gloom. Perhaps there are some areas in which we are actually being provided with even wider horizons.

Behind the scenes, in vision research, they are working hard to provide us with more options that will improve our lives as visually-impaired people. Even casual scanning of research titles show us they are continuing to make progress in such areas as gene therapy and stem cells. Recently, they approved a port delivery system (now called Susvimo) meant to significantly decrease the treatment burden for those with wet AMD who required monthly injections.

This past spring, I completed my term in the third phase of the APL-2 trials. I then moved into a long-term study of the same medication. How will this medication work for people who are on it for years? I am part of the group that will allow them to find out.

Oh, and if and when APL-2 is approved by the FDA? It will be the first treatment for dry AMD in the world. Cool.

I guess what I am saying with all of this is 2021 was a pretty horrific year. For many of us, our vision loss actually became one of the least of our worries!

Yet, with all of this nonsense happening, it appears medical research on age-related macular degeneration has barely missed a beat. Progress was made.

The more I reflect, the more I am reminded of Pandora…and no, I am not talking about music or jewelry. I am talking about that pesky, little girl who, in modern versions of the tale, could not stand to not know what was in the box. When her elders were not paying attention, Pandora opened the box and all proverbial hell broke loose. Fire, flood, pestilence, plague, war, crazy storms and famine were all released.

Pandora looked around at what she had done and was devastated. She desperately looked in the box. Maybe she could fix this? In the box, Pandora found there was still one thing left, hope.

The moral of the story for me is this: I don’t expect 2022 to magically solve all our problems. I still believe we are in for a bumpy ride. Things are out of the box. However, like Pandora, I have hope.

One of my reasons for hope is vision research. Vision research is going at a breakneck pace.

I still hope – believe – a cure for AMD will be found in my lifetime. After all, I say this is the best time in history to be going blind for a reason!

So, welcome to 2022! Fasten your seatbelt and hold on tight! …and when I find Pandora, that little lady is going into time-out!😜

Personal Message December 11th, 2021 Our Genetic Guns: Part 5 and Final

Continued from part 4

Comment 10: Should The Moores Take a LMZ Supplement?

Looks like it would be of benefit to us since:

  1. We are not confident that our diets give us enough LMZ.

  2. We don’t know if our macular pigment and level of carotenoids in the brain are sufficient, which is what this research has shown to be important in reducing our risks of both AMD and Alzheimer’s

Can’t We Just “Pop a Pill”?

Taking a supplement is NOT a substitute for eye- and brain-healthy eating. We will still be eating our leafy green vegetables and colorful fruits and vegetables and other eye-healthy foods to get the other nutrients we need such as Vitamins A, B, C, and E (we were found to be deficient in D so we each take a Vitamin D supplements) and the other essential nutrients. We eat healthy plant-based foods and wild-caught salmon 2 or 3 times a week to get our Omega-3 fatty acids.

First Things First

There are always 2 concerns when considering any supplement:

• Are the ingredients generally safe to take & specifically safe based on one’s medical history & use of medications?
• If they are, which product is the best one as verified by one or more respected, independent testing labs?

Are the Ingredients Safe for Each of Us?

You should ALWAYS talk to your medical doctor before starting a supplement, especially if you have other diseases and take medications. We have different GPs, and we’ve been in touch with them. No problem.

Here are the 2 things I always look for:

  • Are there interactions with the medications we take and the diseases we have? I checked rxlist.com and drugs.com. I checked each of the 3 carotenoids. No interactions for either of us. There are very few issues for anyone, but check it out for yourself.

The 20 years of this research has shown these 3 carotenoids are very safe. There is research to back that up, but it’s beyond the scope of this post.

Comment 11. Which Brand?

I came to this stage in my research feeling confident that taking LMZ was safe for both my husband and me. I had also, to the best of my ability, gone through the research done by Dr. Nolan and his colleagues and felt confident that it met my criteria for solid, scientific research (according to the criteria I listed in Comment 4.)

The next step was to confirm which product was used in Dr. Nolan’s research. It’s what’s currently in the products MacuHealth (available in the US & Canada) and MacuPrime (UK & Europe).

If you watched the ‘Preventing Macular Degeneration Through Science’ video I posted last week (you did, right? ::smile::) you heard Dr. Kerry Gelb say he takes the MacuHealth product when he interviewed Dr. Nolan. Dr. Nolan said he takes it, his wife takes it, and his young daughter sometimes does as well. He and his family have since switched to MacuPrime.

Confusion

If you read the 2014 scientific paper from the CREST trials (you did, didn’t you? ::smile::), you’ll see the product listed as MacuShield. There’s a LOT of confusion about that! I reached out to Dr. Nolan who apologized for it (though it certainly was not his fault). At that time, the company that commercialized the formulation available to Dr. Nolan in the UK was MacuVision Europe, and they branded it as MacuShield. The company was then sold to Alliance Pharma who did not continue with the same formula that was tested. The company in the US that had the world rights to the formulation at the time of the study was MacuHealth (founded in 2006) and the product was then and still is MacuHealth.

Any research after this change in companies was with MacuHealth.

Clarification

Currently, MacuShield is a product only licensed in the UK and Europe. It is a TOTALLY different product than MacuHealth. I confirmed that in an email to the MacuShield company. They were very good and replied clearly & quickly. To be clear (again), MacuShield is NOT the product recommended here.

Bottom Line

MacuHealth products in the US and Canada and MacuPrime products in the UK and Europe are the products that contain the formulation used in Dr. Nolan’s research.

For those who are good candidates for an AREDS2-based formulation, there’s MacuHealth Plus and MacuPrime Plus. For everyone else, it’s just MacuHealth and MacuPrime.

For those who want an AREDS2-based formulation with 0 zinc, you can take MacuHealth/MacuPrime with LMZ and add 500 Vitamin C and 400 IUs Vitamin E separately. That’s the whole AREDS2 formulation.

Please remember my cautions for some of you who are or will be taking an AREDS2-based supplement – those of you with other diseases and who take medications. Please talk to your medical doctor before you start because the doses of Vitamin C and E in the AREDS2 formulation may be too high for you.

Comment 12: More Validation

I could have stopped there, but I wanted to make sure that I did everything for this product that I do for all supplements I choose to take.

Independent Testing

Of course, knowing that others take a product, especially if it’s the researchers themselves, is important, but so is independent analysis of a product.

Consumer Reports

Consumer Reports, a U.S. independent, non-profit organization recommends that since the FDA does not regulate food supplements in the US, it’s important to look for independent labs that test the products to make sure that what is on the label is in it. https://www.consumerreports.org/supplements/how-to-choose-supplements-wisely-a2238386100/

Consumerlab.com

My ‘go to’ independent lab, one recommended by Consumer Reports, is Consumerlab.com of which I’m a member. THEY are confused, too! Even though they are a U.S. company, they tested MacuShield, but not MacuHealth! I emailed them, and they replied that they DO know of the confusion and are working to resolve and report in it. I’m watching for their update.

NSF International

Another source of independent testing referred to by Consumer Reports is NSF International (it was originally the National Sanitation Foundation). The NSF has tested and certified  MacuHealth products (you can see what that means in the Consumer Reports Article above).
https://www.nsf.org/consumer-resources/articles/supplement-vitamin-certification

Supplement Certified

Another certification they have is ‘Supplement Certified,’ another independent lab that I referred to earlier. It’s a new project from Dr. Nolan’s Nutrition Research Centre Ireland (NRCI).
https://supplementcertified.ie/

Company Responsibility

If you listened to the podcast I referred to in Comment 3 (you did, didn’t you? ::smile::), you heard the story of how in one of Dr. Nolan’s clinical trials, when they used an early formulation with just lutein, they unexpectedly found meso-zeaxanthin in it. The trial was stopped, and the company stopped production and sales of the product for over a year. They did produce the new product and the trial continued.

Why Does It Matter?

So if a product has all 3 carotenoids (there are a few), what difference does it make which product you buy?

The lutein in ANY a product probably comes from marigolds. Where the marigolds are grown, what farming methods are used, and how it is processed is important. The processing creates the lutein, zeaxanthin, and meso-zeaxanthin that goes into the tablet or capsule that a person takes. The marigolds used for MacuHealth come from the same fields in Mexico and are tightly managed for specific best-farming methods.

In 2020, Dr. Nolan and colleagues did research (COAST study) to validate a new production method called Micro-Micelle(tm) that MacuHealth uses to make sure the LMZ has the highest possible bioavailability which means how well a substance is able to get into our circulation, to get to the target area, and to do what it’s intended to do. They confirmed that when they take the carotenoids in their ‘free’ form as in the original MacuHealth products, and enhance their stability plus use an oil base because carotenoids are oil solvable, this new technology gives you the best absorption of LMZ.

Read Reviews Online? Misinformation & Testimonials

I rarely do that (they are testimonials, after all), but out of curiosity I went to the Amazon listing for MacuHealth or MacuShield – can’t remember which, and found inaccurate information. Someone asked about MacuHealth and MacuShield: (paraphrasing) “are they the same?” and someone said “yes, they are. It’s the same company, but it’s called MacuHealth in the US and MacuShield in the UK.” WRONG! Yes, I told them that. ::smile::

Here’s another source of confusion. You CAN go to the Amazon US site and buy MacuShield. I emailed the MacuShield company about that since they’d told me they only have a license to distribute their product in the UK and Europe. The seller on Amazon US is a 3rd party distributor. If you purchase MacuShield through Amazon US, you will not get it right away because the 3rd party seller has to get it from the UK!

Got it?

Comment 13: A Beginning and The End

Whew!! Are you thinking, “All this to just pop a supplement? They’re ‘vitamins’ and as such, they can’t hurt!!”

If you’ve been with me long enough, you know how I react to that often-repeated opinion. They CAN and DO hurt SOME people.

However, having gone through this ENTIRE procedure which included talking to the researcher Dr. Nolan and others:

I CAN say that the research shows that taking LMZ in the MacuHealth and MacuPrime supplement is safe!

The Beginning

Change takes time. Making sure we’re getting the proper foods is work and a long-term commitment. We’ve only been taking MacuHealth for 2 months. We’ll be taking it for the rest of our lives.

As for us, I don’t expect to see quick improvements in our vision, but I certainly will be happy to have it be the best it can be as time goes on.

We both have issues with cognitive processing and memory (most likely due to medication), especially word retrieval which is a source of frequent ‘Charades’ (“You know, the thingie that you use for…whatever!”). Maybe someday we won’t have to spend so much time doing that! ::smile::

Not Pulling The Trigger

I started this with the sentence, “Genetics loads the gun, lifestyle pulls the trigger!”

What I HOPE and PRAY I can do is come back in 10 years to say that neither of us have AMD or Alzheimer’s Disease!

The End!

If you’ve read this far, thanks so much! Please let me know if you have any questions.

Personal Message December 11th, 2021 Our Genetic Guns: Part 2

Continued from Part 1

Comment 3. Three (3) Carotenoids, Not Just 2!

I knew that antioxidants are important in battling oxidative stress, so I decided that I should go back to one area that doesn’t get much attention despite its 20-year history of solid research. You probably have heard about 2 of them: lutein and zeaxanthin. There’s a third antioxidant called meso-zeaxanthin.

About abbreviations: Meso-zeaxanthin is often abbreviated as M or Mz, lutein as L, zeaxanthin as Z. Sometimes you’ll see LMZ or LMZ3.

Carotenoids

Lutein, zeaxanthin, and meso-zeaxanthin are called carotenoids. There are MANY others, including beta-carotene. They are pigments that give plants their yellow or orange color. When we eat plant foods, these pigments benefit the body in essential ways.

Macular Pigment

At the back of the eye, at the very center which is known as the macula, LMZ collectively join and concentrate to form a yellow pigment that is called macular pigment (MP). Macular pigment protects the macula from harmful blue light (because it is yellow and can filter out the blue) and provides antioxidants to keep the photoreceptors nourished & healthy to fight oxidative stress.

We Need All 3

The short story is that research has shown that even though there are about 700 carotenoids, only these 3 are found in our macula: LMZ. They have a synergistic effect on each other, which means we need all 3 of them, so they work at optimal levels. Pretty amazing that of all the carotenoids available from nature, the eye ‘chose’ these 3!

Eating Plant Foods

The important thing to know is that if we don’t eat plant foods, we won’t have macular pigment. A researcher quit eating plant foods for 21 days & had virtually no macular pigment at the end of that period. When he resumed a diet which included plants, his macular pigment recovered. https://profjohnnolan.com/wp-content/uploads/2018/05/loughman2012a-bjn-letter.pdf

It also means that if we don’t eat a sufficient amount of plant foods, we don’t have sufficient macular pigment.

It also means that if we don’t eat the plants that contain these 3 carotenoids, we may not have sufficient macular pigment.

Healthy macular pigment, which protects, nourishes the photoreceptors and fights oxidative stress, comes from getting enough of these 3 carotenoids.

With me so far? I hope so!

Comment 4. What Is Meso-zeaxanthin? Why Is It Important? Show Me the Research!

So what is meso-zeaxanthin, and why is it important? To be honest, it depends on who you talk & listen to and what you read. Research frequently comes down to the stories of the people who conduct it. That’s certainly the case with my journey.

The path I followed began when I listened to a September 3rd, 2021, podcast interview with Dr. John Nolan who has been doing research into the 3 carotenoids for the last 20 years (I’ll give you the link in Comment 5). Since then, I have watched countless hours of video, listened to hours of podcasts, and read (or tried to read) LOTS of scientific papers. I have enough of a background, education, and confidence in the scientific method that I felt I was able to understand and assimilate what I needed to be able to follow the research.

Little did I know how MUCH there was, but I was determined to dig through as much of it as I could. That’s why it took so long!

I found that there are many others who were involved and are still involved – quite a multidisciplinary collection of people. I’ll be introducing you to some. These are professionals who have dedicated their careers to the study of macular pigment in the macula which is only about 5.5 mm in the size!

Dr. Nolan (often referred to as Professor Nolan) is not only a scientist & researcher but also a compelling speaker and effective educator. He makes it clear that he’s only one part of this multidisciplinary team that has evolved over his 20-year career. During that time, he became the author or one of the authors of over 100 articles in peer-reviewed journals. You can find all his articles at https://profjohnnolan.com.

In the Beginning

In 2005 in Ireland, John Nolan defended his PhD in Biochemistry on a Wednesday and left for the US on a Friday. He’d applied for and was awarded a prestigious Fulbright Scholarship to study at the Medical College of Georgia. There he worked with researchers who were studying how lutein affects our eyes. [Personal note: My husband got his Occupational Therapy degree at Medical College of Georgia, although he wasn’t there at the same time. I’m always amazed at what a small world it is!]

When he returned to Ireland, he set up the Macular Pigment Research group at the Waterford Institute of Technology. There they began to collect a body of evidence that pointed to the macular pigment as critical to the health of our eyes and as an indication of the level of carotenoids in our brain.

In 2016, he set up the Nutrition Research Centre Ireland (NRCI) where he is the Director. They’re involved in numerous project including the new Supplement Certified program where they are testing supplements to certify that what is on the label is in the product. In 2021, they analyzed 47 nutritional supplements containing carotenoids and found that 64% did not meet the content described on their labels. They are also working with supplement companies, so they make sure that what’s on the label is indeed in the product. Since supplements aren’t regulated, this is welcome news! For more, go to. https://www.supplementcertified.ie

Continuing Down the Path

There’s MUCH more to Dr. Nolan’s biography. I hope you’ve read what I wrote in the Events post (Facebook page) which is more complete.

Here are the reasons I chose to continue:

⁃ Dr. Nolan’s research is based on recognized scientific methodology, where the results are published in peer-reviewed journals. In the world of scientific research, there’s something called the ‘Hierarchy of Evidence.’ Although the details vary from country to country, Level 1 scientific evidence means it was obtained through randomized, controlled clinical trials. Dr. Nolan’s research has been Level 1. https://en.wikipedia.org/wiki/Hierarchy_of_evidence

⁃ He does not work alone. He repeats this over and over in his articles and interviews. He frequently refers to people he’s worked with over the years. This isn’t a ‘one man show.’

⁃ His research depends on objective measures of the levels of the carotenoids in blood, the macula, and the brain. He uses state-of-the-art equipment, equipment that has improved significantly over the years.

⁃ He does not work for any company exclusively. He has tested many supplement products. The main funding for his research comes mostly from government sources, including that of Ireland and the EU.

⁃ When he first started using an LMZ formulation from a specific company, it was with the agreement that he would publish the results no matter what they were. And he did!

NEXT: PART 3 –COMMENT 5. DR. NOLAN’S RESEARCH: HIS QUESTIONS AND ANSWERS

Personal Message December 11th, 2021 Our Genetic Guns: Part 1

A Personal Message from Me, the Founder and Administrator of This Group. December 11th, 2021.

This began as a project for my Facebook Group founded in May 2016 to be an extension of this site. The day before I posted it, I decided that it should be here, too, for anyone who can benefit. I apologize about the ‘comment’ format. I hope it’s not too distracting.  – Linda Chernek Moore.

Who should read this?

Everyone who is concerned about eye and brain health:

• those with and without macular degeneration,
• those with and without cognitive problems, including Alzheimer’s Disease.

In my opinion, that means everyone here.

My Journey Story

I will – for the first time in over 5 years here – tell you what supplement my husband and I take and why. I will take you step-by-step through the process of how I came to select it for us.

This isn’t a sales pitch because I’m not actually promoting a product, I’m actually promoting good scientific research.

Why am I sharing it in what seems to be a ‘big way’? It’s because I think it is important. You probably know how cautious I am about supplements. I do not promote the “It’s a supplement/vitamin, it can’t hurt!” They CAN hurt some people. I have many examples of that.

This is one of the FEW times I’ll be able to say, “It can’t hurt! It’s safe!”

Our Genetic Guns

My dad had advanced dry AMD/geographic atrophy. My husband’s mother had AMD, but we’re not sure of the type. Neither of us have AMD – yet – but research has shown that we each have a higher risk of it than someone with no family history. We each have additional risk factors as well.

There’s another disease for which we both have an inherited risk factor: Alzheimer’s Disease. My mother had it. We think my husband’s mother had it as well, although it may have been another form of dementia.

In memory of Harry & Genevieve Chernek and Elizabeth & Jacob Moore

I’ve shared this quote that’s often used for discussions of genetics:

genetics loads the gun, lifestyle pulls the trigger.

What does that mean? It means that a person may have a specific genetic makeup that predisposes them to a disease, but lifestyle factors DO matter. They can prevent the expression of the genes or can lessen the impact of them.

With family histories of AMD -and- Alzheimer’s, our guns are loaded!

We are COUNTING on those lifestyle factors! I’m 68 and my husband is 70. There’s a third risk factor: age. They’re both age-related diseases, so our guns are REALLY loaded!

Comments

I’ve been working on this in ‘fits and starts’ since early October, so it’s been almost 2 months. I hope I’ve managed to put together a coherent description of this long process. Because there’s been so much to it, I’ve put the details in the comments (on the Facebook page, that is). Here is an outline, so you can go to what you’re interested in if you don’t want to read the whole story.

Outline

1 The Eyes and the Brain: Same Lifestyle Factors
2 Oxidative Stress and Antioxidants
3 Three (3) Carotenoids, Not Just 2!
4 What Is Meso-zeaxanthin? Why Is It Important? Show Me the Research!
5 Dr. Nolan’s Research: His Questions and Answers
6 Where Do People Get LMZ? My Questions and Answers
7 Time to Get Personal: Are The Moores Getting Enough LMZ?
8 Can The Moores Improve Their Diet?
9 Those of You With AMD: Your Benefit
10 Should The Moores Take a LMZ Supplement?
11 Which Brand?
12 More Validation
13 The Beginning and The End

Comment 1. The Eyes and The Brain: Same Lifestyle Factors

The eyes are actually part of the brain, so it’s not surprising that what benefits the eyes, benefits the brain. If you’re not familiar with the connection between the eyes and the brain, here’s a brief explanation. https://youtu.be/4Na0Mj0b_6A

Lifestyle Factors for the Eyes and the Brain

The same lifestyle factors affect them both. Nutrition and smoking are the main ones. I never smoked, but my husband did but quit 40 years ago.

I started my investigation with nutrition because of our continued struggles with the Mediterranean way of eating, which is recommended for both diseases. We try our best to eat healthy but found that we were falling short of the very specific nutrition advice given frequently.

Not Just Healthy Eating

Years ago I found out that ‘eating healthy’ does not necessarily mean ‘eating healthy enough for the eyes’ and now discovered the same thing applied to eating healthy for the brain! Much more to it!

Comment 2. Oxidative Stress & Antioxidants

In both diseases, oxidative stress is a major factor because research has shown that it leads to inflammation, which leads to diseases such as AMD and Alzheimer’s. I wanted to make sure I understood the terms oxidative stress, free radicals, and antioxidants.

What Exactly IS Oxidative Stress?

Think about an apple that you cut and is exposed to the air. It changes & spoils the apple, doesn’t it? Also, think about what rust is. Both processes are from oxidation, which means something is exposed to oxygen and is changed.

Some people say that since we depend so much on oxygen, aging is just rusting! Lovely image, huh? Soon I’ll be introducing you to Dr. John Nolan who says this is “the cost of doing business with life.”

In the body, oxidation is a chemical reaction in a cell when it is exposed to oxygen. Our retinas use the most oxygen of any cells, so that’s a LOT of oxidation!

In these cells, there can be an imbalance of what are called free radicals (the ‘bad guys’) and anti-oxidants (the ‘good guys’).

Oxidative stress is when the ‘bad guys’ are getting control, which is NOT good! Here’s a short video that explains this.
https://m.youtube.com/watch?fbclid=IwAR2pV_Z35dnfoWxdzx9IXdmQSm9t6MfMR1VAkHCsAkFCQHNlB9b3ks69XS8&v=9OgCjhAFCC0&feature=youtu.be

Oxidative Stress and Inflammation

Oxidative stress can trigger inflammation which is thought to cause dis-eases (yes, I purposefully put in the -) like AMD and Alzheimer’s, or at least it’s thought to be a major factor. For more information about the effects of oxidative stress on the body—> https://www.medicalnewstoday.com/articles/324863#summary

Anti-oxidants

So to battle oxidative stress, we need a good and consistent supply of anti-oxidants (that is ‘anti’ for ‘against’ & ‘oxidants’ referring to oxidation and oxidative stress; I’ll leave out that ‘-‘ from now on).

This 15-minute video is the first part of a Continuing Medical Education course which gives a GREAT explanation of the process and introduces the role of the 3 powerful antioxidants that are critical to protecting and nourishing our photoreceptors, which are the cells that convert light to sight. ‘Macular Pigment Supplementation: A Prescription for Vision and Cognitive Health.’
https://youtu.be/-8n9rz2AmXE

I highly recommend part 2 as well.

Next: PART 2 – THREE (3) CAROTENOIDS, NOT JUST 2!

Personal Message December 11th, 2021 Our Genetic Guns: Part 3

Continued from Part 2

Comment 5. Dr. Nolan’s Research: His Questions and Answers

Perhaps the best way to understand how this research evolved over time is to listen to Dr. Nolan describe it in detail before he joins us on Tuesday, December 14th (see the Events section on the Facebook group’s page). It was this podcast from September 3rd, 2021, that helped me to understand how the researchers started by looking at lutein and then measuring and testing all 3 carotenoids.
‘Age-related Macular Degeneration, Supplementation, and Key Research Findings in the Field of Ocular Nutrition.’
http://broadeye.org/nolan/?fbclid=IwAR29J6lcBxCYHkAGuV8wTfsxD7t6cbnNieWFC8U1wLihlVrcStYcR_0DC0g

The Questions

What’s clear from the podcast is that he approaches all his research as you should – with questions. The basic ones were:

  • Can we prevent eye diseases like AMD by enhancing the macular pigment?
  • By optimizing all 3 carotenoids in the macular pigment, can we improve contrast sensitivity (ability to detect differences in shading and patterns), reduce glare issues, improve photostress recovery (ability of vision to come back to normal after exposure to bright light) and other measures of vision in everyone with or without AMD?
  • Does the measurement of the macular pigment give us an indication of the levels of the carotenoids in the brain?
  • Does enhancing the level of carotenoids in the body prevent a disease like Alzheimer’s?
  • Does enhancing the level of carotenoids in the brain help improve memory and cognition?
The Answers

The answers after 20 years of doing study after study were yes, yes, yes, yes, and yes!

He and his colleagues were able to move beyond subjective measures to objective measures that could be validated and reproduced.

Summary

As far as the research about our eyes, they not only looked at the ‘traditional’ measure of vision which is visual acuity, but objectively measured contrast sensitivity, glare sensitivity, and other aspects of vision. Having sufficient levels of LMZ meant significant improvements in these measures.

As far as research about Alzheimer’s, they not only looked at preventing the disease but at improving memory and cognition.

Understand My Excitement?

I hope you understand why I was so interested in the work he and his colleagues did and continue to do 20 years later!

Onward!

After digging through all the research I could and talking to Dr. Nolan personally to fill in the gaps, it was now time to apply the findings from the research to my life and my husband’s.

Comment 6 Where Do People Get LMZ? My Questions and Answers

So MY big question at this point was:

If we need all 3 carotenoids, can we get them from our diet by eating plant-based foods?

Although we can get enough lutein from plant-based foods, it’s harder to get zeaxanthin and almost impossible to get meso-zeaxanthin because it’s found only in the skin of some fish like trout and shellfish. We don’t eat trout or shellfish.

Somewhere along the line before this project, I’d read that zeaxanthin & meso-zeaxanthin are made from lutein in the body.

There are researchers who believe that the body metabolizes lutein and produces meso-zeaxanthin so as long as we’re getting enough lutein, we are fine.

Dr. Nolan says that he believes that SOME people do produce meso-zeaxanthin from plant foods, but not everyone. He’s done extensive testing of people’s macular pigment over the years and estimates that 15% of the population don’t have optimal macular pigment for whatever reason.

What reasons? Not getting enough lutein? Getting enough lutein, but their body isn’t converting it to meso-zeaxanthin? The ‘jury is still out’ on this, but it may be because of a lack of certain enzymes.

Next: PART 4 – TIME TO GET PERSONAL: ARE THE MOORES GETTING ENOUGH LMZ?

Personal Message December 11th, 2021 Our Genetic Guns: Part 4

Continued from Part 3

Comment 7: Time to Get Personal: Are The Moores Getting Enough LMZ?

How do WE know if we are among those who get enough lutein from our food and make enough meso-zeaxanthin from it? We don’t.

What I understood at this point from the research:

This is big!

This is the key to stopping that genetic gun from firing!

Since we cannot get a measure of our macular pigment, we have to assume it’s not as healthy as it needs to be to prevent both diseases.

Comment 8: Can The Moores Improve Their Diet?

My husband and I have had general concerns about our nutrition for some time:

  • We have trouble finding produce that we’re convinced is nutritious because there are well-documented problems with farming, distribution, and availability.

  • We often don’t get the vegetables cooked properly. Sometimes they are in the refrigerator for too long. Our health issues mean that some days we just don’t have the energy to prepare a healthy meal, even though we have the food.

  • We both have diseases for which we take medications, so we know we don’t absorb nutrients from food as well as someone with no other diseases and who do not take medications.

  • Because of our age, we don’t absorb nutrients as well as someone younger.

Even if we were to try to follow the Anti-AMD Diet that I refer to frequently (see Guide 11), the daily recommendation is to eat 6-7 servings of fruit and vegetables a day: 2.5 cups of vegetables & 2 cups of fruit). A serving is ½ cup cooked, 1 cup raw. The vegetables should include leafy greens, but I’ve not seen any recommendations of the ratio of leafy greens to other vegetables.

That’s a LOT! Do YOU eat this every day? We certainly don’t!!

Comment 9: Those of You With AMD

So far, I’ve shared research that says that having the optimal amount of LMZ in the macula is linked to the PREVENTION of AMD which applies to me, my husband, your kids, your grandkids – those of us with a family history – and your friends and neighbors who do not have AMD or a family history of it.

Want Me To Fast Forward? Sure!

You’d like me to fast-forward, right, to the part where I tell those of you who already have the disease what, if anything, LMZ will do for you?

Relief From the Symptoms

Full disclosure: this is not about slowing the disease – at least we don’t yet know/haven’t proven if having optimal macular pigment reduces the risk of AMD progressing to an advanced stage such as wet AMD or Advanced Dry AMD/Geographic Atrophy. Those types of clinical trials take a LONG time.

We DO know it is about:

  • protecting the photoreceptors from further assault and damage from oxidative stress;

  • improving the symptoms that make vision with AMD problematic: problems with glare and contrast, slow recovery from bright light, slow dark adaptation;

  • protecting the photoreceptors from damaging blue light. Here’s a great video where Dr. Nolan talks to Dr. Kerry Gelb about it. https://youtu.be/wpV4dWd3_80

AREDS2 Formulation Plus Meso-zeaxanthin for Some

What HAS been shown is that for those who are good candidates for an AREDS2-based formulation – those with intermediate dry AMD or with wet AMD in one eye but not the other – adding meso-zeaxanthin DOES improve vision while providing that same reduced risk of progressing to wet AMD found in the AREDS & AREDS2 research.

Dr. Nolan’s CREST Trials

In 2011, Dr. Nolan received funding from the European Research Council to do 2 trials called ‘Central Retinal Enrichment Supplementation Trials (CREST).

Their research question was: if we enrich a person’s macular pigment by giving them LMZ as a supplement, can we improve visual function as measured by contrast sensitivity as the primary endpoint and visual acuity, glare disability, and other measures of vision as secondary endpoints.

CREST AMD (sometimes referred to as CREST 2)

There were 2 CREST trials, but I’m leaving out the details, including those for Trial 1. Dr. Nolan can fill us in about it (and a lot of his OTHER research that I’ve not discussed – there’s just been SO much!).

Trial 2 is called CREST AMD, so they studied people with early AMD. Their primary measure was contrast sensitivity. There were 32 tests in all!

There were 2 treatment groups who both got a supplement with the ingredients from the AREDS2 formulation: Vitamin C and E and 25 mg of zinc, lutein and zeaxanthin.

Group 1 also got meso-zeaxanthin.

You’ll find a good graph in this article that shows the results. The article says, “Patients with AMD would have usually been expected to experience a continued deterioration in their vision throughout the 2 years of the clinical trial. Instead, those receiving carotenoid supplementation showed a significant improvement across 24 out of 32 tests of vision. Improvements in vision were particularly marked among those patients receiving all three carotenoids (group 1) compared with those receiving only Z and L (group 2). Of note, 34.8% of trial participants who received all three carotenoids had what is deemed to be a clinically meaningful improvement in their vision after 24 months, compared with 19.6% of patients on the AREDS2-like formulation (see Figure 1).”

‘CREST AMD Trial: Vision Improvement Among Patients with AMD Who Consume Xanthophyll Carotenoids’ https://www.optometricmanagement.com/newsletters/nutritional-insights-for-clinical-practice/may-2018

What If Your AMD Is Beyond the Early Stage?

It’s not been studied, I’m sorry. However, since we know that LMZ protects the macula from further damage from oxidative stress and from further damage from blue light and has proven to reduce symptoms of glare and contrast sensitivity, improves dark adaptation, and improves photostress recovery, I think it’s safe to assume it will have a positive effect for you, too!

It’s Also About Alzheimer’s

No matter what stage AMD you have, LMZ also reduces your risk of developing Alzheimer’s Disease. Every time there’s an article about the link between AMD and Alzheimer’s Disease, it causes quite a stir.

The connection isn’t between AMD and Alzheimer’s: it’s the connection between the eyes and the brain!

Next: PART 5 AND FINAL-COMMENT 10: SHOULD THE MOORES TAKE A LMZ SUPPLEMENT?

Wolf Pack and the Letter T, O, and R – The End!

Back to the last of the pages on physical treatments for dry age-related macular degeneration. I have been trying to do these in alphabetical order. Unfortunately, I have a confession to make: I don’t know my alphabet. I missed one! Oh well, what do you want? We are wolves. We travel in packs, not in schools! [Groan. This series has really gotten to Sue! ::grin::]

The scent trail we missed was intraocular telescopes or lenses. This procedure is done on people with very advanced disease. And guess what? This is a scent trail that the pack actually might want to follow! There is some evidence that for people who have lost a great deal of their sight to dry AMD intraocular telescopes and lenses may just improve quality of life.

At least two studies were of good quality and yielded good results. There were some cases of increased ocular pressure, but these did not appear to be that serious. As of the publication of the article (2018), there were clinical trials running in both the UK and the US. If you have significant vision loss, a little telescope in your eye might be a way to improved quality of life.

Okay, wolf pack! We are back on the trail forward. Sometimes we have to double back to a potentially promising trail, but now the next stop is O for ozone.

In the ozone treatment they remove some of your blood, treat it with ozone and replace it. Apparently, this procedure was only being researched by one group in Italy. This lack of replication studies is a red flag suggesting this trail might not be “fresh” for us, wolf pack. Good research needs to be replicated by others. In addition, the studies themselves suggested very minimal improvements in vision. Ozone looks like a false trail, wolf pack.

This leaves us with one more scent trail to follow from this article. This is rheopheresis. Once again, this potential treatment involves the drawing of blood. Only this time the blood is filtered to remove larger molecules before it is returned. The process is said to take several hours and several sessions are required. The theory is reducing the thickness of the blood will improve circulation in the eyes.

Bottom line for this one was also a dead end. Sample sizes were small and results were not very robust.

So, what does all of this mean for us, wolf pack?

Basically it means we, as the pack, go hungry tonight. In the area of physical interventions for AMD, at least based on this article, the pickings are pretty slim. There is very little in this neck of the woods to get us wound up and yipping in excitement.

But that is alright. The pack has gone hungry before. We are cunning and patient. We know a false or a cold trail when we smell one, and we don’t follow it no matter how hungry we may be. There are other patches of woods out there. We will explore those instead. Somewhere there is a fresh trail, and we will find it.

Remember: There are many, different, proposed treatments and “cures” for AMD out there. The great majority of them have not been proven and may only end up being a trap for you, your time and your money. Evaluate carefully every “scent trail” you come upon. Be calculating and cunning. Be the wolf.

Next: I’m sure it will be worth the wait!

Wolf Pack and the Letter M & N

So far, our wolf pack has eyed a variety of “prey.” Every one of the options we have thus far reviewed from the 2018 article Physical treatments for age-related macular degeneration has not satisfied our hunger for a serious, effective intervention. Some of them have shown promise, but none have definitely been found to be what we are looking for.

Believe it or not, that is okay. The wolf pack does not waste time and energy on prey they cannot catch. They do not waste time and energy on potential prey that will not satisfy their needs. They are discerning and shrewd, and we must be the same.

With that in mind, fellow wolves, let us move on to the letter M!

In this article, the letter M stands for microcurrent stimulation. Microcurrent is used in treating musculoskeletal pain. Some of you may have TENS units that do this. However, in this case, they decided to see if very low levels of current administered to the eye could help with dry AMD. The thought is this may be a way to increase neuroprotection by activating the neurons in the eye.

The data available at the time the article was written suggested microcurrent may have some promise, but there is no good understanding as to why. At least one study suggested there might be increased blood flow in the eye layer called the choroid. (My OCT scan pictures show my choroid. That is because there is a hole where my photoreceptors and RPE s once were.) A couple of other studies suggested there might be some changes in chemical signaling (your eye cells do talk to one another. Their language is chemicals.) There was also some indication the microcurrent would be able to interfere with pre-programmed cell death.

Now on to the conclusions about this research. Once more, microcurrent has not been scientifically found to be effective. There were only three studies found to review and none of these offered robust results. At this time, microcurrent appears to be another unworthy target for the pack. Don’t waste time and energy following this scent trail, wolves! It does not look like this is prey for us.

Bring us to the letter N for night-time light. We have mentioned dozens of times that drusen are simply eye poop, the fatty, metabolic waste of the cells in your eyes. The theory has been slow down the metabolism in the eye, and you will create less eye poop and consequently fewer drusen.

According to this section of the article, for some weird reason, eyes are more metabolically active in the dark. The theory is this: keeping light in your eyes all night will lead to the slowing of the metabolic process of the eye and result in less eye poop.

Interesting theory, but there was no research to prove or disprove it as of the publication of the paper. Consequently, one more false trail. Don’t let your nose lead you down this trail, wolves. One more, there is no satisfying kill at the end.

So, so far there have been few promising trails for us. Going down any of these trails will not result in satisfaction of our hunger. Maybe there will be something more substantial somewhere later in the alphabet? We will see.

Next: WOLF PACK AND THE LETTER T, O, AND R – THE END!

Wolf Pack and the Letters B & L

Lin/Linda here: in her previous page, Sue wrote about a wolf pack: “I would like to think we are the pack. I know we are hungry for treatments for AMD. I would like to think we are cunning enough to pick good targets in our hunt for these treatments. I want to believe our hunger will not lead us to be deluded by some “quacker” offering empty promises …and a quick buck for himself.” She continues.

The last page I wrote started to share information about dry AMD treatments from research done in the UK at the request of the government. So far I have gotten to A….this might be a long series!

In the article by Waugh et al., B is for blue light. The blue light idea comes from knowledge that the macular pigments lutein and zeaxanthin absorb blue light as a protective action. Blue light appears to be a factor in AMD progression. The question for research became this: would reduction of blue light slow damage caused by AMD? There were four literature reviews found. Unfortunately, these reviews came to different conclusions. There was no definite proof that replacing the natural lens with a blue-light filter lens in cataract surgery gave a great deal of protection against AMD. Likewise, there was no evidence using a blue-light filtering lens in cataract surgery did any harm.

While there is a long-term study being done in Japan, right now it appears the decision to get a blue-light filtering lens during cataract surgery is a matter for you and your doctor to decide on an individual basis. It may be more a matter of preference than a matter decided by science.

The conclusion on blue-light filtering lenses and AMD seems to be “might not help, but probably won’t hurt either.”

Lucky for you, we get to skip the letters C though K and go on to the letter L. In our alphabet here, L is for laser. That is specifically laser photocoagulation treatment of early age-related macular degeneration. The idea behind laser photocoagulation is to blast drusen before they get too big and prolific and start robbing us of our sight. While the process is not yet well understood and is definitely more involved than playing Blaster Master, there is evidence that laser photocoagulation enhances the clearance of debris (affectionately known on this site as “eye poop”) as well as doing a few other, beneficial things I did not understand.

Like all things that are being investigated, laser photocoagulation therapy has a few kinks that need to be straightened out. There are questions about the types and intensities of the lasers used. For example, in early work a too hot laser appeared to cause a more rapid progression to wet AMD. While they are now using “cooler” lasers and firing them for only milliseconds, there are still things to work out before lasers can be considered a bonafide treatment by most.

The take home message for laser photocoagulation is it is a definite maybe. There were several high quality studies either in process or about to launch when my reference article was published in 2018. They may help determine whether laser photocoagulation therapy has an effect on the development of age-related macular degeneration.

Just a caveat here: at the risk of being a killjoy, I need to remind you that none of the treatments reviewed here are able to restore lost photoreceptors. That means there would not be a significant improvement in vision. What they are hoping to do is to reduce the progression of the disease.

Considering that is where the state of science is presently and, considering I am a very willing lab rat in a clinical trial trying to reduce the rate of progression, that is good enough for me. Hope it is good enough for you as well.

And with that said, the hunt is on! I do believe our next target for consideration is an M word.

NEXT: WOLF PACK LETTERS M & N

 

Happy New Year 2021!

Here we are at the end of another year…or at least I am hoping we are at the end! 2020 has…shall we say…stunk! I mean, England had a hurricane-like thing recently. Whoever heard of England having “hurricanes”? And that is only a minor inconvenience when you compare it to a pandemic, a recession, a record number of hurricanes here, wildfires and, oh yes, a crazy political scene. Getting 2020 in the rearview mirror sounds like an enticing idea.

2020 was supposed to be our year. For obvious reasons 2020 was supposed to be the year we made great strides toward eradicating blindness. Lin has shared with you information on things like End Blindness 2020 and the World Health Organization’s initiative Vision 2020. There were supposed to be amazing things done this year! What happened?!?

Actually, amazing things have happened. Really. I would not lie to you. While we have hit a few snags, great things, amazing things have happened.

Dan Roberts compiles a yearly list of the progress being made. As some of you know, I was tapped to be a “lab rat” in the APL-2 clinical trials a few years back. I am proud to say, “my” study is the first one Roberts mentions in his list of innovations being made…ok, so I have done nothing but ride down there every month and let them put a needle in my eye, but I am still proud!

Although we were shut down for several months due to the pandemic, the delays were not that significant. Both Roberts and I are thinking APL-2 may easily become the first treatment for advanced, dry age-related macular degeneration also known as geographic atrophy. We are both also thinking this Apellis product will be on the market in late 2021.

Roberts also makes mention of other advancements. Port systems for the administration of anti-VEGF are on the near horizon. These would allow the number of eye shots to be reduced significantly in those with wet AMD.

In his summary, Roberts mentions the ever-increasing collaboration of groups and experts around the world. Building on each other’s successes really does allow us to build the proverbial better mousetrap and everything else. While Roberts is speaking of supporting organizations, I would point to the collaboration in science. Did you notice the number of immigrants represented in the development of the COVID-19 vaccines? Speaking of AMD as well as COVID-19, we are truly in this together and will make more progress when we support one another. It is a small world.

Last of all, Roberts refers to the revolutions in artificial intelligence and telecommunication, particularly Telehealth. I would add to his points that my life as a woman with visual impairment has been made much easier by the technological revolution we are experiencing. I expect it to get even better with time.

And keep in mind this is just a small fraction of what is happening in the fight against vision loss. When you look at the research you see a wide range of potential innovations. Regenerative medicine? Gene therapy? Cyborg-sounding things like miniature cameras in eyes? Yep. All being worked on. While I am thinking APL-2 will be the first treatment for dry AMD, you should have no doubt, there are other treatments in development and snapping at its heels, all anticipated to do great things.

So, yes, even given this stinky year nearly behind us, there is hope. And coming up to the fifth anniversary of my diagnosis of legal blindness, I have to say that hope for those of us with vision loss is getting stronger every year. And I assert once again, this is the best time in history to be going blind.

Best wishes for a blessed – and much better! – new year!

Written December 27th, 2020.

 

 

Catching Up – December 2020

Hi. It has been absolutely months since I wrote a page for this website. With COVID-19, my workload as a therapist has expanded. In addition to my day job, I was asked to do a side gig writing for a “health community.” Add to that my “doom scrolling” of online news outlets to check on the pandemic and election, and I have managed to let a few things slide.

As some of you know, Lin, my friend, editor, webmaster and purveyor of many good things, has had some serious health issues that are hopefully mostly behind her now. Her reasons for being m.i.a. from the website are much better than mine. [Lin/Linda here: thanks for the kind words, but we both have perfectly good reasons for not being here – they’re just different. ::smile::]

All by way of saying, sorry and making a pledge to do somewhat better. Not that we are going to present the quantity of material that we used to. Come the end of January, 2021, I will have been legally blind for FIVE years! How time flies when you are having “fun.” After that amount of time, I have adjusted. In some ways, being visually impaired has become old hat. I don’t have the angst I once had and my life is pretty routine. In other words, I can be really boring! And, yes, being visually impaired can be boring, too.

That does not mean, however, that everything is boring about my geographic atrophy. A few of you may know of my quest to some day regain my sight. Yep. Cockeyed optimist that I am, I have every intention of someday no longer being legally blind. The first step in my diabolical, master plan was to get into a clinical trial. That goal was reached about 18 months ago.

Since that time I have been going monthly for injections of a trial drug. The earlier results of the study suggested this drug, APL-2, slows down the rate of degeneration by about 30 to 40%. If things continue to progress at the rate they are now, it is not inconceivable that the first, clinically proven treatment for geographic atrophy will be on the market by 2022.

And it might not even be “my” drug that wins that race to be the first treatment for GA. The concept behind “my” drug – interfering with the complement cascade – is also the underlying concept behind other treatments in the pipeline. Those drug trials are doing very well also.

The second step of my diabolical plan was to get into a long term study that would hold me over until step three was ready. I am supposed to achieve inclusion in a long term study in the spring. The study is to determine how years of use of the drug affects my eyes. Will I develop side effects? Will the drug continue to work as well? Worse? Better?

I am willing and anxious to get into that study because it is a stepping stone to my next objective. That objective is a study that currently only exists in my feverish, little brain…and maybe the brains of a few researchers. That study will see how well transplanting RPE stem cells into eyes treated with the drug works.

After that? By that time I am speculating they will be ready to transplant photoreceptor cells and get them to connect to the optic nerve. Endgame. We see again. [Check out the Audacious Goals Initiative of the NIH NEI (National Institute of Health, National Eye Institute). That’s what they’re working toward.]

At least that is my diabolical plan. Step one will be completed and step two will start in the spring. I love it when a plan comes together.

If you are ready and able to join me and thousands of others as “lab rats”, if you are ready to become part of the solution, please volunteer for clinical trials research. Remember, this really is the best time in history to be going blind.

Written December 1st, 2020.

Hope Through Research – Second Quarter 2020

There are so many research studies in progress for AMD that it’s hard to put them all into one article so I’ve been writing and collecting a series of articles. The research ranges from early, pre-clinical trials (in the laboratory) where they’re studying the disease process to the potential replacement of an eyeball! In between there is research into:

  • cures for macular degeneration and other blinding eye diseases
  • better treatments for wet AMD
  • actual treatments for dry AMD
  • gene therapy research to stop macular diseases including AMD as well as types of macular degeneration caused by genes
  • stem cell research to replace retinal cells that are damaged
  • ‘bionic’ vision which is any of a number of types of vision improvement using technology which includes retinal implants, lens implants, implants into the visual cortex of the brain,and even eyeball replacements!
  • technology to help those with low vision such as the existing headworn devices and the ones being developed

Find Out More!

A Cure!

A Cure in Our Lifetime? There are many groups of people and organizations around the world who are working toward a cure!

Summary 2019

Summary of Research and Developments-2019

Audacious Goals Initiative

The NEI Audacious Goals Initiative: Bold Research to Restore Vision. An older article but this initiative continues today.

Dry AMD

Have Dry AMD and Wonder When There Will Be a Treatment?

Wet AMD

Have Wet AMD and Hoping for Something Other Than Injections?

Gene Therapy Research

Gene Therapy Research for AMD. Stopping the Disease

Stem Cell Research

Restoring Vision: Retinal repair: Bringing stem cells into focus

Stem cell transplantation: Restoring vision in AMD may be possible

My 2-part article ‘Retinal Repair Using Stem Cells – Background & Current Status–> (there’s a link at the bottom of part 1 that will take you to part 2)

Bionic Eye

Can refer to a retinal implant, a lens implant, brain implant or the replacement of the eyeball.

New Bionic Eye Research: Computer Chip Implanted in Retina for Those With Severe Vision Loss

Retina Implant, Stem Cell Studies Set for Space Station

Technology

Technology for Those with Low Vision: Have Vision Loss? “One to Beam Up!”

Retinal Repair Using Stem Cells: Part 2 – Current Status 2020

There have been stem cell trials for retinal repair going on in various locations around the world since the FDA approved their use for retinal repair research in 2010.

Warning: there are no FDA-approved stem cell trials outside of research. Why is that important? Check out the first article in this series for the details.

The Problems in Early Research

The goals of the continued clinical trials are to solve these problems:

  • There have been ethical issues with using embryonic stem cells related to religious and political disputes about when life begins.
  • Early research using embryonic stem cells found that these cells were often rejected.  That means that if they are used, the participant takes immunosuppressant drugs exposing them to other diseases. Also, early research found that sometimes these cells migrated and caused tumor growth outside the eye.
  • Stem-cell-induced RPEs injected in a suspension under the retina didn’t stay in that area to integrate with the person’s RPE cells.
  • The method of getting these stem-cell-induced RPEs into the retina through a  surgery called a vitrectomy adds to the risk of adverse effects such as retinal detachments.

I am greatly simplifying this topic because it IS complicated! If you would like a detailed review of this period of time, check out Retinal stem cell transplantation: Balancing safety and potential. It’s written using highly-technical language, but I think the conclusion is clear:

“The promise of stem cell therapy to preserve or restore vision in retinal degenerative diseases is finally taking shape. Whereas a decade ago, such ideas were confined to basic and translational laboratories, in the current era, stem cell transplantation into the retina is finally in human clinical trials in the setting of well-run registered clinical trials with the oversight of the FDA and appropriate ethical and safety review infrastructure built in. These aspects promote the protection of study subjects from undue harm, and facilitate the dissemination of the results to the scientific community and the peer review process.”

Status as of 2018

If I counted correctly, there are 18 clinical trials listed in a chart in the article Stem Cell Therapy in Retinal Disease. Sometimes they are called ‘RPE transplantation.’ They vary in:

  • location of the research: US, UK, Japan, China, and others.
  • source of the stem cells: embryonic, autologous cells which are cells taken from the participant (bone marrow, blood, skin).
  • how the stem-cell-induced RPEs are organized:
    • loose in a suspension which is a fluid or
    • on a single layer of some kind of material (monolayer) that connects them to keep them together. This simulates how normal RPEs are positioned on Bruch’s membrane. The designs and composition vary, but some other terms for this approach are patch, scaffold, layer, implant, or sheet.
  • type of delivery method: injected into the vitreous fluid or inserted below the retina using various procedures.
  • type of retinal disease: AMD both wet and dry, Stargardt’s Disease, Myopic Macular Degeneration and Glaucoma.

Status in 2020

There are 3 stem cell clinical trials that have been making headlines in late May and early June 2020.

London Project to Cure Blindness

In 2015 in a phase 1 UK clinical trial, stem-cell-derived RPEs on a patch were inserted into the retinas of 2 people who had vision loss from wet AMD. In 2018, it was reported that they had gone from not being able to read at all, even with glasses, to reading 50-80 words per minute with normal reading glasses.

A recent update said that 5 years later, these 2 people have retained this improvement. There are other people enrolled in this clinical trial. When the COVID-19 lockdown has lifted, they will be treated.

Lineage Cell Therapeutics OpRegen Clinical Trial

For those who have advanced dry AMD called geographic atrophy (GA), there are 2 issues:

  • There are areas of no vision from dead photoreceptors which are called scotomas or blind spots.
  • These scotomas continue to grow and vision loss gets worse.

In 2015, the company Lineage Cell Therapeutics started a phase 1/2a clinical trial in locations in the US and Israel using their biologic product OpRegen. OpRegen is a suspension containing human embryonic stem cells. There were 4 cohorts (groups) where the treatment varied by the severity of the GA of the participant, 1 of 2 forms of the suspension, the delivery system used, and the number of cells use. For some of the participants they used a delivery system they developed called Orbit Subretinal Delivery System which delivers the stem cells into the retina without the need for a vitrectomy.

The FDA ‘fast tracked’ the clinical trial because “the drug fills an unmet medical need in a serious condition.” That means it will get faster communication and review with the FDA (more details in ‘BioTime’s Subsidiary Cell Cure Neurosciences Ltd. Receives FDA Fast-Track Designation For OpRegen® For The Treatment Of The Dry Form Of Age-Related Macular Degeneration.’

Preliminary data for the 5 participants in cohort was presented in 2020. The findings were:

  • The stem cell product and new delivery system were safe and well tolerated in all 17 participants.
  • For 5 people, there was an average of a 10 line increased in visual acuity over the 15-month followup period.
  • Testing showed improvement of the RPE area with a reduction of the amount of drusen and a decrease in the size of the scotomas of some participants.

National Eye Institute

After positive results using animals, the National Eye Institute announced a Phase 1/2a clinical trial in which a person’s own blood will be used to create stem-cell-induced RPEs that will be transplanted into the retinas of 12 participants who have geographic atrophy. There are two important aspects of this clinical trial:

  • By using a person’s own cells, it reduces the chance that the body will reject them. That reduces the need for Immunosuppressant drugs.
  • The stem-cell-derived RPEs are put onto a single-cell (monolayer) biodegradable scaffold or patch. It’s the first clinical trial in the US to do this.

As a phase 1/2 trial, the participants will be monitored for a year for adverse events to make sure that the stem cell patch and procedure to insert it are safe. Based on the promising results of past stem cell clinical trials, they also hope to see improvements in visual acuity.

Hope for Those With Vision Loss

Vision loss from the advanced stages of any type of macular degeneration is devastating. This line of research has advanced greatly in 10 years. There have been promising results so far. Current and future research is building on those results to give HOPE that vision loss can be stopped and even reversed!!

 

Retinal Repair Using Stem Cells: Part 1 – Background

Research into macular degeneration is aimed at:

  • stopping the disease from developing
  • treating it so that the disease process stops
  • reversing damage that has been done
  • curing it

I’ve shared many examples of each of these areas. You’ll find links at the end to 4 of my articles about research for wet AMD, for dry AMD, for gene therapy research, and for a cure.

In this article, we’ll look at what’s being done in clinical trials to reversing damage and to restore vision that has been lost.

Reversing Damage That Has Been Done

What about those who have an advanced form of macular degeneration and have suffered vision loss? This can occur in any form of macular degeneration including AMD, Stargardt’s Disease, and Myopic Macular Degeneration. The stem cell research applies to all of these.

Vision loss occurs when the photoreceptors die. These cells transmit signals to the brain which is where we get our sight. They convert ‘light to sight.’ They die because the cells that keep them alive called RPEs (Retinal Pigment Epithelium) falter and die. These RPE cells are critical to the retina’s ability to dispose of waste and to make sure the photoreceptors are nourished. We know that retinal cells don’t regenerate, so researchers have been asking the questions:

Can we keep the RPE cells healthy? Can we replace RPE cells that have died? If we do that, can we restore vision that is lost?

There is research into replacing photoreceptors, but it’s more difficult to do. It is currently being explored in the lab and with animals which is called pre-clinical research. 

Restoring RPE Cells – Restoring Sight?

The answer to those questions about RPE cells have been found in the area of stem cell research. What are stem cells? They are specialized cells in our body that can make other types of cells. No other cells can do that. The stem cells used in research come from different sources. You can learn more about them in National Institute of Health’s Stem Cell Basics and A Closer Look at Stem Cells.

Here’s a very simplistic explanation as to why stem cells are of interest in retinal repair:

  • If they can make other types of cells, can they make RPE cells? The answer is yes! These new RPEs are called stem-cell-derived RPEs, and they’re created by the ‘magic’ of science (it’s complicated!) in the lab.
  • If we could take those stem-cell-induced RPEs and get them into the retina, could they replace failing or dead RPEs and keep the photoreceptors alive?

That’s exactly what researchers are working on.

Warning

The topic of using stem cells is one that has been discussed in MANY areas of healthcare. For retinal repair, there is NO proven safe and effective use of stem cells as a treatment for macular degeneration outside clinical trials which follow procedures that are rigorous and based on the scientific method. The first step is to establish the safety of the proposed treatment – that’s Phase 1. Only if the treatment is proven to be safe do the clinical trials progress to find the right dosage needed to be effective and to monitor any side effects. FDA approval comes at the end of a series of phases. You can learn more about clinical trials and why they are important by reading Treatments and Cures: Too Good to Be True? You can also find out what the FDA does and does not do related to macular degeneration.

Beware Unproven So-Called Treatments

Some people and clinics sell these unproven, not-FDA-approved stem cell treatments for macular degeneration. These costly procedures have blinded people & have not been effective for others. For more information about that, you can read FDA Warns About Stem Cell Therapies – Some patients may be vulnerable to stem cell treatments that are illegal and potentially harmful. The FDA has been working to shut down the sellers – that’s what they are – of these possibly dangerous procedures.

Unreliable Resource

The NIH National Library of Medicine has an online resource available called clinicaltrials.gov. It’s where researchers can list their studies which can be accessed by patients, their family members, health care professionals, and the public. Unfortunately, the site has no oversight, no vetting of the entries to make sure they are legitimate studies. Just because you find something that sounds interesting to you or someone you love, it doesn’t mean it is something to seriously pursue. You need to do much more research. I recommend the article Nine Things to Know About Stem Cell Treatments.

Stem Cell Research for Retinal Repair

The FDA approved their use for retinal repair in 2010. You can read about the early research in the 2018 article Stem Cell Treatment in Retinal Diseases: Recent Developments.  Also, you can watch a great 2018 video Retinal repair: Bringing stem cells into focus.

The study of using stem cells is called regenerative medicine.

The Basics

Since retinal repair research started in 2010, the studies have varied primarily in two aspects:

    1. The source of the stem cells. The options used so far are embryonic stem cells and induced pluripotent stem cells which are adult cells that are reprogrammed to look and act like embryonic stem cells. You can read about these in What Are Stem Cells and How Do They Work.  The more recent research has moved to using the induced pluripotent stem cells for several reasons: use of embryonic stem cells has raised ethical issues, they are hard for researchers to get, have a higher risk of rejection, and they can migrate to other places with a possibility of creating tumor cells.
    2. The method of transplanting the stem-cell derived RPEs. The purpose is to get these new cells in the area of the RPEs so they can be integrated with them. Initially, the cells were put into a suspension (a fluid) and injected into the retina. Unfortunately, those stem cells didn’t stay where they were placed. With the help of engineering experts, more recent research has put these cells on a monolayer (single layer) of a material to keep them together so that when they are implanted in the retina, they will stay in that area. The designs vary. Some other terms for this approach are patch, scaffold, layer, implant, or sheet.

Summary of the Concept

The basic way stem cell research is conducted is that ‘new’ RPE cells are created in the lab from stem cells and injected into the retina. Hopefully, these stem-cell-derived RPEs should then integrate with the person’s own RPE cells so that they can do what RPE cells do: nourish and clean up after photoreceptors. Sounds simple, yes? It isn’t. There are issues regarding rejection of these new cells and the safety of using immunosuppressive drugs, their possible migration to other places in the body where they may create tumors, safety of the method that delivers the stem-cell-derived RPEs, and more. That’s why the clinical trial process is so important!

The History

As I wrote above, the FDA approved the use of stem cells for retinal repair in research in 2010. Phase 1 clinical trials started that year. The purpose of phase 1 clinical trials is to make sure the treatments are safe. Since stem cell research for retinal repair was so new, researchers were very careful. These early studies used embryonic stem cells with their possible complications. One early trial was stopped out of concern for the participants

Since then, many clinical trials have been done.

When doing your own research on this topic, make sure to check the dates of the resources since much has changed since 2010.

Two early Phase 1 studies were started in 2010 by Advanced Cell Technology (then called Ocata which became Ocata Therapeutics; it’s Astrellas currently). Professor Steven Schwartz, MD, and colleagues reported that 4 months after the first patients had the procedure they found no safety issues of tumor growth or rejection from using embryonic stem cells and no loss of vision. In 2015, they reported that of the 18 patients treated, more than half had improvements in visual acuity. They found evidence that the new RPE cells were integrated in the retina. They also reported that although the treatment was safe, which meets the objective of a phase 1 clinical trial, more follow-up was needed. 

I could give you a LONG list of articles about the clinical trials that came after this one. A lot of progress was made, a lot was learned. I want to fast-forward to where we are today with this promising research.

Next: RETINAL REPAIR USING STEM CELLS: PART 2 – CURRENT STATUS 2020

More Research

A Cure in Our Lifetime?

Have Dry AMD and Wonder When There Will Be a Treatment? 

Have Wet AMD and Hoping for Something Other Than Injections?

Gene Therapy Research for AMD. Stopping the Disease

Don’t Panic!

If you ever read The Hitchhiker’s Guide to the Galaxy – and I would recommend you read it if you have not and/or recommend you read it again if you have – you may remember one bit of sage advice : don’t panic!  This bit of advice is offered repeatedly to our hero, Arthur Dent, as he travels through the Universe, fleeing from the destruction of the Earth to make way for an intergalactic bypass and seeking  to find the answer to the questions of life. That answer, by the way, is “42”.

Don’t panic! You don’t have to understand it. Just enjoy the workings of a delightfully warped mind. Thank you, Doug Adams!

And I repeat: don’t panic! Lin informed me there was recently a piece on the possible links between age-related macular degeneration and Alzheimer’s. She remarked a few of you, well, panicked. Don’t do that!

Is it possible? Of course it is possible. The eye is the only part of the brain we can actually see without any messy surgeries or fancy machines. As part of the brain, your eye can, of course, get “brain- diseasey” things going wrong.

This does not, however, mean we are doomed to get dementia!

A couple of things to keep in mind. Number first: these are the very early days of this research. We really do not know much. Number second: the studies I saw were correlation studies. Correlation does not mean causality. In other words, just because two things look to be related it does not mean they are. And it especially does not mean one caused the other!  Serious logical boo boo there.

I found the article I believe the other source was citing. I also found a 2014 JAMA Ophthalmology piece on the Association Between Age-Related Macular Degeneration, Alzheimer’s and Dementia. This was also a correlational study. After comparing nearly 66,000 AMD patients and nearly 17,000 Alzheimer’s patients the researchers discovered “considering AD and other dementia after AMD, their coexistence at the individual level is no different than that expected by chance.” In other words, they did not see ant evidence that AMD leads to Alzheimer’s.

Meaning? Don’t panic!

That said, you, me and just about everyone else I know would not get in line if the sign said “Get your Alzheimer’s here!”  I would run rather rapidly in the opposite direction. In fact, I am “running” in the opposite direction several times a week right now.

I am doing this by actively working on my health and my cognitive skills. Vascular disease seems to be related to both AMD and dementia. It is important to take care of your heart and circulatory system.  Take your medication, eat right and exercise regularly.

Much of my exercise is repetitive, rhythmic activity. That means I am thinking pretty much all of the time I am moving. I tell my hip hop instructor he is my secret weapon against Alzheimer’s. Just trying to figure out his steps and follow along give me as much a mental workout as the actual dancing gives me a physical workout.

I am also still working, playing video games (silly, easy ones), socializing, traveling, writing a blog and reading. In other words, if “use it or lose it” applies to cognitive skills, I am doing all I can to keep using them. Not lose them.

Bringing me back to Doug Adams and The Hitchhiker’s Guide to the Galaxy. If you want a few mental gymnastics, read and follow along if you can. Watch those wicked, left turns. And by all means, don’t panic!

Bad News, Good News

OK, so I like listening to myself talk. I decided to write another page. Lin is going to love this but I kinda miss writing sometimes.

Anyway, if I am going to write more, you might want to give me some assignments. It keeps me from rambling on. Sort of a self-defense move on your part, and I am still a half decent researcher. You might get some good information in return.

Enuf of that.

This page is going to be bad news – good news. Bad news first. According to the August 1, 2019 Healio ophthalmology post, yellow glasses do nothing to improve night driving. In a study by Hwang et al, people wearing yellow lenses ran down just as many simulated pedestrians as the folks not wearing the glasses. Pooh.

The bottom line for this study was leave your money in your pocket and do not invest in yellow-lenses driving glasses.

The commercials target older drivers because we have a lot more trouble with night vision and night driving. We are also more affected by oncoming headlights. Yellow lenses did nothing for that problem either. Spend your money another way.

Bad news number next is this: Eylea injected in the non-wet eye does not help to prevent it from going wet. Again in Healio, this time July 27 of this year, it was reported that in a two year study trying to use Eylea prophylactically, it didn’t work. In other words, the percentage of the group who converted to neovascular AMD was just about the same whether they received the Eylea injections or not. It appears that using Eylea to try to keep an eye from converting to wet has no positive effect.

And one more time about that word “converting”. Remember all AMD starts out as “dry”. Geographic atrophy and “wet” or neovascular AMD are both just different end stages of the same disease. Therefore, LumiThera products and complement inhibitors like APL-2 may conceivably help slow the progression of the disease so that people won’t ever have to worry about converting. Cool.

Now in the interest of fair and balanced reporting, let’s look at two, positive reports. First of all, Healio ophthalmology reported in their July 28, 2019 post that they are making progress with the so called “patch”. An ultra thin piece of probably polymer with stem cell derived retinal pigment epithelial cells was slid through the subretinal space and positioned within the geographic atrophy lesion.

The big news here is the delivery method. Using the subretinal space means no vitrectomy and no opening up the center of the eye to possible infection. It is a procedure that could eventually be done on an outpatient basis. Also, the study proved they were able to put the patch where it was needed with very respectable accuracy. Good going.

And another quick review: RPEs do no seeing. RPEs are the “servant cells” for the photoreceptors that do do the seeing. Replacing RPEs is a great step because it puts the support system back on the job. Somehow you have to replace the photoreceptors.

Won’t they just grow back? Nope. Skin heals. Bones heal. Neurons do not heal and photoreceptors are neurons.

Never fear, however, because our superheroes, the researchers, are on the job. Last year, September, 2018 the Review of Ophthalmology reported the first regrowth of rod cells in mammals.

Exciting, yes, but don’t throw the party quite yet. The mammals were mice and they regrew rod cells. We primarily lack cone cells. Just the same, the researchers at Mt. Sinai in NYC are expanding the frontier and getting us ever closer to real cures for blindness.

How do you like that for good news?

Written August 5th, 2019

Next: WANNA SEE MY BOO BOO?

Lab Rats Unite!

Hi! Long time, no write much; I know. I have, however, been lurking in the background and Lin has been keeping me apprised of some of what is happening. Certainly not all, but some.

Some of what she has said involves Facebook members and clinical trials. You guys rock!

Lin told me one member has been patiently/impatiently waiting for a trial with LumiThera. That was the page I just did “on assignment”. The one on photobiomodulation.

Lin also told me a member was being recruited for a clinical trial using stem cells. The member thought of me – and my obsession with stem cell research – and wondered why I was not being included. After all, one of the sites is Philadelphia.

First of all, I want to thank the member for thinking of me. The way we are going to get this stuff beat is to all work together both sharing and advancing knowledge. I am feeling that our time has come and the research is advancing quickly. This is because thousands of people like us are willing to be “lab rats” to get the job done.

Secondly, I want to address his query as to why the stem cell obsessed old lady is not beating down doors to get into this study. A big reason is this: they don’t want me!

I agreed to do the APL-2 study several months ago. I have integrity and am good to my word. Also, clinical trials most often look for treatment naive subjects. That means you cannot have been in any other study.

Another reason is my eyes are not bad enough. This is a phase 1 study and the best corrected acuity for this study is 37, pretty impaired.

Phase 1? A quick review here: phase 1 studies are for safety and tolerability only. Are you going to have something really weird happen? What are the reactions to this procedure and can we put up with having those reaction? Any effect achieved is gravy. We look for the effects when we do phase 2 which is a “proof of concept” phase.

Now 37 as a measure of acuity had me a little stumped. I am used to the ever popular 20/xxx notation. That is you can see at 20 feet what normal eyes can see at xxx feet.

Precision-Vision.com published a handy dandy little Visual Acuity Ranges and Visual Acuity Notations chart. The thing is sort of a Rosetta Stone for equivalent notations, true Snellen fractions, magnification requirements and – voila! – visual acuity scores. Turns out visual acuity scores are no more than letter counts.

If you have a visual acuity score as required by the stem cell clinical trial, your Snellen fraction is worse than 20/320. In other words you see at 20 feet as well as people with good vision see at 320 feet or even further away. This is in the severe vision loss range.

My vision is probably in the moderately impaired range. Those are Snellen scores from 20/80 to 20/160 according to the chart. Bluntly put, I got in the APL-2 study partially because they are confident enough they won’t screw things up that they are willing to give the experimental treatment to people who still have fair vision.

The LumiThera treatment? Guess what all you folks with mild vision loss…that one will be for you! They are working with light therapy to reduce drusen size before there is significant vision loss. Yippee!

So, here we are, working together to share and advance knowledge. Severe loss, moderate loss and mild loss people all pitching in to contribute where they can. Sort of gives you a warm and fuzzy feeling; doesn’t it?

And by the way, guys? You rock!

Next: Bad News, Good News

Sue on Assignment: Photobiomodulation

Lin asked me to do a little research on photobiomodulation therapy. She told me she has at least one Facebook group member who has been waiting to get into a clinical trial with LumiThera, a company in the field.

Ok. Since I know exactly nothing about photobiomodulation, I guess that means I get busy on the web!

According to an article by the Vielight company, photobiomodulation therapy is defined as the utilization of non-ionizing electromagnetic energy to trigger photochemical changes within cellular structures that are receptive to photons.

Whoa.

The take home message there is light can be used to trigger processes that repair cells and promote healing. Different wavelengths of electromagnetic energy, such as light, cause different reactions. Different intensities of radiation have different effects.

Different parts of the body also react to photobiomodulation. The Vielight article talked about using electromagnetic energy to treat neurological issue.

Considering someone once described eyes as the only part of your brain you can see, it is not surprising they would also be using it to treat diseases of the eyes. In a 2016 article in the International Journal of Ophthalmology, Ivayla Geneva looked at how photobiomodulation – also known as low-level laser therapy – can be used to treat retinal diseases including retinopathy of prematurity, diabetic retinopathy, and age-related macular degeneration. She described it as a promising therapy that is low cost and non-invasive.

Photobiomodulation therapy consists of a series of brief illuminations of generally near-red or infrared light using a laser or a light-emitting diode ( LED). The long wavelengths of red light allow for deep tissue penetration.

The Geneva article was based on pre-clinical studies from 2015 or so. That is, it was mostly very promising rat lab stuff that is now around five years old. That can be ancient history in science. It also was a very technical article and referenced a lot of what is going on at a biochemical level. Way above my pay grade! What is actually happening now?

Moving up to 2017, Acta Ophthalmologica published an internationally collaborative study by Merry, Munk, Dotson, Walker and Devenyi. This was the first study to demonstrate improvements in both functional vision and anatomical outcomes using photobiomodulation with dry AMD. Merry et. al. found positive changes in best corrected vision, Drusen volume and Drusen thickness. Contrast sensitivity was also significantly improve.

The above quoted study was the opening salvo in LumiThera’s series of clinical trials attempting to use photobiomodulation against dry age-related macular degeneration. It led, of course, to another, larger study. Called LITESITE, this study launched in 2016 in Canada.

LITESITE II started operations as of March and, according to Clinicaltrials.gov, was still recruiting as of July 10. The bad news for many of us is all, ten research sites are in Europe! They are running the study in England, France, Germany, Italy and Spain.

OK. Let’s put on our deerstalker hats and play Sherlock Holmes for a second. There’s Canada, Latin America and Europe. Where is the United States?

It appears that even though LumiThera has won multiple awards for medical innovation, it has not even started being vetted by the FDA. This should probably start soon, though. In February of this year the National Eye Institute gave LumiThera $2,5 million to start research here.

When I say “soon”, of course, we have to understand that is a very relative term.

Clinical research requires astronomical amounts of money. $2.5 million is barely enough to start. Other “Daddy Warbucks” will be needed.

In the meantime? Keep an eye on LumiThera. They may have the first, proven treatment for intermediate AMD.

Finally a Lab Rat

Hi! Things here are crazy. Absolutely going around in circles. I have a full counseling client load and am teaching not one, but two psychoeducational groups. Also trying to get some summer stuff going such as keeping the pool clean and cleaning out some stuff for the animal rescue group’s yard sale.

If I did not know I do it to myself all the time, I would feel sorry for myself!

But, no, I am not asking for sympathy. Just a little slack. It has taken me longer than it should have to tell you I was chosen for the study.

As I said, it is APL-2. It is a complement factor inhibitor. That means, again, that it interferes with the series of chemical reactions that leads to the complement immune reaction. The complement immune system, according to Wikipedia, is part of the innate immune system and therefore helps to make up the older of the two immune systems (innate and adaptive).  The innate immune system is sooo old  – your line: “how old is it? “ – that it is the immune system in plants, fungi, insects and primitive multicellular organisms. Jeez. Leave it to me to get a glitch in something that should have been perfected, like, a million years ago.

Anyway, activation of the complement cascade leads to the identification of bacteria, marking them as targets and the clearance of cell debris. That would be great, but for one, small problem. Since AMD is an autoimmune disease, the “target for tonight” is our own, healthy cells. A little bit confused, I would say.

The chemical in APL-2 is believed to “take out” a molecule that is involved in all three channels or courses or whatever that are part of the complement cascade. It is pretty far “upstream” as compared to some other treatments they have looked at in the past.

Be that all as it may, the study is double blind. That means I have no idea which of four treatment groups I may be in. My “handler” does not know either. Also, the doctor who does my measurements doesn’t know. The only thing I know is I am supposed to “get a shot” every month. That means I am either in the monthly treatment group or the monthly sham – read faking the shot – group.

After hearing some of the problems people who get regular eye shots have, I don’t know what to believe. Why? Quite honestly, I have felt exactly nothing and there is no evidence I have had a shot. No discomfort, no puncture mark, nada. I go back and forth between thinking there is no way it can be this easy and I must be in the sham group to thinking they really are that good at sticking people in the eye with needles!

Weird talent but I am going to assume I am actually getting the shots and be glad they display said talent. Might as well be positive. I will not know for sure until the trial ends in three years.

So that is that. After three and a half years I have achieved the coveted status of lab rat. It may not be the study I wanted but it was the one offered and I am finally fighting back. Feels kinda good.

Written June 23rd, 2019

Next: Lab Rats Unite!