Category: Research

Timeline Part 1: Advances in Treatment & Care for People with Macular Degeneration

It’s Lin/Linda.  I created this page to go with Sue’s page Not Your Parents’ AMD.  Like some of you, I had a loved one with AMD.  It was my father who was diagnosed with AMD in 2005 at the age of 82.  At the time, I was living 700 miles away and I did not know much about the disease or at what stage he was diagnosed.  He progressed to geographic atrophy (GA), that much I knew.  He was the sole caregiver for my mother who had Alzheimer’s Disease.  He continued to drive (not safely), take care of her and the house.  He was never referred to vision rehabilitation or offered any help other than being told to use handheld magnifiers.

I wondered how things have changed since then which led me to do this timeline review.  Not only have there been advances in the medical end of the field but also in the technology that is allowing people to remain independent for as long as possible.  That is if a person learns how to use the various devices and apps available.

I’ve based the categories of time on an article Age-Related Macular Degeneration
1969 –2004: A 35-Year Personal Perspective by Stuart L. Fine, MD published in 2005.  He says “In 1969, patients with AMD constituted a small part of a typical ophthalmic practice. From 1969 to 2004, the prevalence of AMD has increased, and the methods of evaluation and treatment have changed dramatically.”

I know I have missed many events that have been critical to the history of the treatment & care of AMD.  There is SO much information out there and I’ve tried to use the most significant dates I could find.  Have a suggestion of what to include? Did I get a date wrong? Let me know in a comment or send me an email at light2sight5153@gmail.com.

1st Era: 1969–1979
  • Emergence of fluorescein fundus photography: test used in diagnosis of retinal diseases
  • Development of ‘hot’ (high power) laser photocoagulation, first treatment for wet AMD
  • Relationship of drusen to age-related macular degeneration
  • Other developments:
    • 1976-1977 first personal computers affordable for home use
    • more low vision aids:
      • 1960s large print books became available
      • 1976 large print calculators became available
      • 1969-1970 CCTV (closed caption TV) for reading aid
2nd Era: 1980–1994
  • Clinical trials to evaluate new treatments, especially laser photocoagulation (1979-1994)
  • Development of risk factor data from large and small epidemiologic studies (epidemology is looking for patterns & causes)
  • mid-1980s term ‘senile macular degeneration’ becomes ‘age-related macular degeneration’
  • Other developments:
    • 1982 Vitreous Society was founded; 1983 first meeting attended by 44 retinal specialists
    • 1991 OCT (Optical Coherence Tomography) test used in diagnosis of retinal diseases
    • mid 1980s name changed from ‘senile macular degeneration’ to ‘age-related macular degeneration’
    • 1992 Americans with Disabilities Act (ADA)
    • 1983 first cell phones
    • 1991 World Wide Web for ‘surfing’ the Internet with easy-to-use browsers
    • low vision aids:
      • MaxiAids catalog of aids for orders from people with low vision & other impairments
    • technology/low vision aids:
      • 1982 DragonSystems founded Dragon NaturallySpeaking, speech to text
      • 1988 ZoomText was released which is software to magnify text on a computer screen
3rd Era: 1995–2003
  • Evaluation of radiation therapy for neovascular AMD, not proven to be effective
  • Assessment of pharmacologic interventions for neovascular AMD; Photodynamic Therapy (PDT) “cold” (low power laser) with Visudyne (first drug treatment;  2001)
  • Prevention trials: results AREDS released 2001
  • Other developments:
    • 1995 Amazon sells books online (1998 expands beyond just books; e-books 2000)
    • 1996 Google released
    • 1998 first e-book reader The Rocket
    • 2000 GPS available for civilians; 2001 personal navigation systems available like Garmin and TomTom
    • 2000 Microsoft & Amazon sell e-books
4th Era: 2004 – 2017
  • Completion of ongoing trials for neovascular AMD: FDA approval: Macugen 2004; Avastin 2004; Lucentis 2006; Eylea 2011
  • Earlier identification of eyes at risk: regular use of OCT (Optical Coherence Tomography) and other diagnostic tests
  • Prevention trials: results AREDS2 released 2013
  • Increased number of retinal specialists: eg, American Association of Retinal Specialists (ASRS), formerly Vitreous Society (see 1982 above), has 2700 members representing 60 countries.
  • Other developments:
    • 2011 First baby boomers turn 65
    • 2004 Facebook
    • 2013 first ‘bionic eye’ retinal implant, Argus II approved by FDA
    • technology:
      • 2007 Amazon Kindle e-reader; iPhone & Apple IOS
      • 2008 Android 1.0 & Android phone
      • 2010 Apple iPad
    • technology/low vision aids:
      • 2005 Apple VoiceOver for Mac users
      • 2009 VoiceOver added to iPhone IOS
      • 2010 FDA approved implantable telescope
      • smart glasses/wearable technology
      • 2014 KNFB Reader app for Apple & Android; 2017 for Windows 10
    • ongoing research areas:

I Want to Be a Mutant

I want to be a mutant. Oh, not like the X-Men although it might be cool to be Storm. I want to be a mutant because those are the people who respond the best to lampalizumab.

A friend emailed me an Associated Press piece entitled Drug shows progress against vision-robbing disease in seniors. Although this was the first time I have heard this, according to the article, ‘lamp stuff’ doesn’t do a bit better in people with the specific gene mutation, it does a LOT better!

I had heard that lampalizumab produced a 20% regression in lesion progression. That, folks, appears to be an average.

Those with the complement factor I risk allele actually had a 44% reduction in geographic atrophy progression. Wow!

To me, this is the first BIG indication genetic testing and AMD treatment have to be closely associated. I really do NOT want to be poked in the eye with a needle every month if the treatment won’t do any good. Likewise, I will be more amenable to said needle poking if I know I have the gene and I can slow my vision loss by nearly half. Not to mention how insurance companies would respond if they knew they could save money by eliminating non-responders from the pool.

Now, you need to remember all of the hard sciences are not my forte, but it seems to me complement factor I is a molecule that helps to trigger the action of the immune system. Remember all that stuff about whether or not AMD is an autoimmune disorder? It appears complement factor I is able to slow down some aspects of immunity that are running amok and attacking the good guys as well as the bad. Once again the theory appears to be our sight is being wiped out by friendly fire.

Musing here a moment, I have a very strong immune system. Never had mumps or chickenpox. Only had one form of the measles. In the 50s and 60s when I was small, kids got those things all of the time. Once more, I was the odd one. But what if my great immunity is not the result of a strength but actually of a weakness? To wit, I have an immune system with bad brakes. That is a thought. After vanquishing all the bad germs, it turned on itself. Put that with a strong family history of RA, another autoimmune disorder and it makes you wonder. Things that make you say Hmmmm….

Anyway, lampalizumab tightens loose brakes on immune reaction in those who have the complement factor I risk allele. It keeps the immune system from running wild and reduces the rate of damage about 44% in geographic atrophy.

I don’t believe the genetic testing we were given for trial measured the complement factor I risk allele. However, I should suspect changing the genes they highlight may not be that big a job. I also suspect making that adjustment would be a big moneymaker (This is America, after all).

So, next we should probably all find out if we are mutants. I have dibs on being Storm. Who wants to be Wolverine or Charles Xavier? [Can I be Wolverine? Love what he does with his nails!]

written June 28th, 2017

Continue reading “I Want to Be a Mutant”

Holy Steve Austin, Batman!

“We can rebuild him. We have the technology.” – quote from the 1970s TV show “The Six Mission Dollar Man”.

Now the Pentagon is looking to equip American soldiers with bionic vision! Holy Steve Austin, Batman!

Granted, that might be something we question the wisdom for, but hold on, it is possible we might just benefit!

Lin found an article actually from 2015, but prior to this, the information had slipped right past us. It seems they have been working on contact lenses for macular degeneration. Anyone interested in becoming a cyborg?

We are going that way of course. Pacemakers, neurostimulators and wearable technology are all pointing in that direction. However, some of the wearable technology is clunky and well, ugly. These things go in your eyes and no one will be the wiser. Only my ophthalmologist knows for sure.

Right now everything is experimental. It will probably not come to fruition for several years, but the concept is intriguing. The lenses are a little thick and they don’t allow the eyes to breath as they should. They are not comfortable enough to wear for extended periods.

What is cool about the lenses is you can switch back and forth between 2.8 x magnification and regular vision. Blink one eye for magnification and the other to go back to normal view.

We will keep watch for developments in contact lenses as well as all, other areas of endeavor. Lin commented today on how crazy fast the research and discoveries have been coming.

I know I sound like a broken record, but there is much reason for hope. Together we WILL break the back of this thing.

And since that was less than 300 words, what else is happening? Well, I found an article on lutein. Lutein is a yellow pigment produced by plants. Although the assumption has been lutein is good for your eyes, it is thought to protect against light-induced retinal damage. The article, Safety and Benefits of Lutein, published by the National Capitol Poison Control Center, suggests a great deal more research is needed. This is particularly true for very large quantities of the substance. So far the only side effect known of lutein is it sort of turns you yellow.

According to the article, AREDS did not find lutein to have much effect in slowing AMD. However, there are larger amounts of lutein in eye vitamins than in basic supplements. Go figure.

Right now it appears they have not found any evidence to suggest lutein is harmful but they likewise have not found any evidence that says it is particularly useful, either. As in most areas of life, moderation appears to be the key. And remember, if you start to turn yellow, that is too much! Continue reading “Holy Steve Austin, Batman!”

Geez, It’s Dark in Here!

Back again. I don’t want to scrub the floor or score a test, soooo….a page!?

Still checking out short blurbs from Modern Retina. Rosenfeld reported that low-luminance visual acuity deficits are predictive of the rate of geographic atrophy (GA) progression. Low-luminance visual acuity is basically night vision.

Following up on this I discovered that back in 2008 Janet Sunness found GA patients who reported poor night vision were much more likely to go legally blind than their GA peers who could see better at night. These people made up the quarter of their GA patients (visual acuity of 20/50 or better) who became legally blind within four years.

I believe them but still have a couple of questions. Recovery time from being ‘blinded’ by bright light is forever for me. Leave me there and come back in an hour.

Night vision is not bad. I prefer to walk without a flashlight because I see better to navigate. How can that be considering I am one of those who became legally blind?

The study measured night vision by seeing how much could be read in low light conditions. Reading in low light, I am not so good. Maybe that is the difference.

Anyway, if you cannot afford a lot of fancy testing, seeing how much you can read at dusk may give you some idea of how bad things are going to get. Just what we want to know; right? How bad things can really be.

And in other news, inflammation remains a target for the AMD researchers. Lampalizumab, aka ‘lamp stuff’, blocks complementary factor D to help control the alternative complement pathway (that thing again!) and reduce retinal inflammation. ‘Lamp stuff’ is said to work with carriers of the complement factor I at risk allele. Considering​ Regillo wants to start poking needles in my eyes come 2018, I cannot help but wonder if I actually have that gene. I would hate to be poked in the eye every month to no good end.

Maybe I would rather use POT. ?That’s POT 4. POT4, aka APL 2, blocks all three pathways of complement action at the same time. They are looking to develop an intravitreous shot that would be very long-term. None of this four to six weeks business.

And talking about shots, I just lost the article somewhere in this mess (not domestic goddess material; remember?) but I also read a short article taking about a new, medication delivery system they are working on in the UK. This team has been working on developing a little, bitty molecule that can permeate the layers of the eye and deliver medication to the retina through daily eye drops and not monthly shots. Not only will the people getting the shots approve, but the NHS (National Health Service) will approve because it will cut the number of office visits way down. Save money. Ka ching! [Lin/Linda: never fear, I found the article, click here.]

So there you have a review of some of the articles I pulled off of Modern Retina. They have lots in the works. Some of it is promising and some proves not to be, but they are zeroing in on treatments (plural because with a condition caused by multiple genes I believe there will be multiple avenues of attack). We are getting closer to answers. There is hope. Continue reading “Geez, It’s Dark in Here!”

Reading Modern Retina

Never thought I would be skimming back issues of Modern Retina, but here I am! Let us get back to some of the science stuff.

Amyloid beta is a major component of plague found in the brains of those with Alzheimer’s. There has been some suspicion AMD and Alzheimer’s are related at a genetic level. A recent study completed by Cheryl Guttman Krader failed to show any positive effects of injecting an antibody that targets amyloid beta into the eyes of those of us with geographic atrophy.

For the time being this means this line of inquiry will be abandoned or re-worked. Proof of concept did not occur and these researchers might go on to investigate something else.

Why are negative findings good news? One less blind alley to investigate! Since we don’t know which ideas may bear fruit, they all have to be investigated. Eventually we get to only the ones that have the most promise. Scientific method.

And another reason I think this finding is good news? It sort of suggests the Alzheimer’s and AMD connection may not be so cut and dry. Phew!

Here is another failure in proof of concept. Aflibercept is called Eylea when it is used as an inhibitor of vascular endothelial growth factor (VEGF – read “one of the things that makes the extra veins grow in AMD”). Michelle Dalton tried implanting stem cells in the eyes of patients who had been getting Aflibercept. She hoped the stem cell would produce the natural vascular endothelial growth factor and make the shots unneeded.

Unfortunately, many more patients than she had hoped required rescue doses of the drug. However, she also had people who kept the stem cells alive and these imported new stem cells did produce some of the Anti-VEGF molecule. Quantities were just too far below a therapeutic dose.

While this may be a failed experiment on the face of things, it is not all bad. Knowing there was some production of the desired molecules means this procedure may be very helpful once they figure out why it worked the little bit it did. Magnifying that effect may lead to fewer injections.

Last one, David S. Boyer wrote a review on multiple strategies being investigated for treating dry AMD. While many protective strategies for our photoreceptors and RPEs have failed, one they are still looking at with interest is brimonidine, brand name Allergen. Allergen is once again an intravitreally administered drug. (That is needle in the eye. We appear to be destined to join our wet AMD friends in that fate!) Coming out of phase 1 trials, brimonidine looks good. Next for it is phase 2, proof of concept. Will it perform as hoped?

Glatiramer acetate is looking good for reducing drusen. Glatiramer is used to treat multiple sclerosis, a disease in which the immune system wears away at the covering on the nerves. The theory is that glatiramer acts as a decoy to mitigate the autoimmune reaction. This treatment is based on the idea AMD really is an autoimmune disease.

There has been some evidence glatiramer reduces drusen, but Dr. Boyer warned us drusen can become fewer on their own. Drusen regression.

And that is a topic for another page.

written June 26th, 2017

Continue reading “Reading Modern Retina”

BIG News!

Woke up with a start at 2 am last night. Probably several things.

First thing that happened was a call from one of my contracts. She had called my third place of employment to schedule an evaluation and was told I did not work there anymore!

News to me! Now, I don’t get there a lot but the plan was for me to go and do a case or two when called. Maybe something like once every six weeks or so. I was never told I was being fired!

Of course it turns out someone got something wrong but it did get me to thinking. Once again, how does one graciously bow out or – hopefully equally graciously – be shown the door? Inquiring minds.

The second thing that has me a little anxious is my big ‘field trip’ tomorrow. I am going to do some sightseeing on Manhattan with an acquaintance from school. First time that far away from home without my husband since my sight loss. I know it can be done, but it is still a little scary.

Third thing: I saw Regillo yesterday. My eyes are getting worse slowly. (I am not so sure about the slowly part!) He confirmed scotomata (aka blind spots) get darker but did not necessarily say they go black. He said that he would not expect a central vision loss to cover 60 degrees of arc. That wide a loss would be ‘extreme’. Those two answers at least get us slightly closer to settling two of my burning questions from this Spring.

The big news, though, is he wants to try me on lampalizumab next winter. It appears the phase 3 clinicals are going to wind down by the end of the year and phase 4 trials will be starting.

People, the numbers of subjects in phase 4 trials is BIG. HUGE! Phase 4 trials take place after the FDA approved the marketing of a new drug. The drug is made available to the public through local physicians. They look for effects and side effects in diverse populations.

What this means for you is simply this: the first actual TREATMENT for geographic atrophy may only be six months away! This is the first breakthrough!

Lampalizumab is an injectible drug. It has been proven to slow the progression of geographic atrophy and to “reduce the area of geographic atrophy” by 20%. Dosing occurs monthly or every six weeks.

Will I do it? Probably. I really believe stem cell replacement of RPEs is the way for me to go, but it is taking forever and I don’t have time for forever. Lampalizumab can be administered locally and would avoid lots of trips to Philly. I don’t like the idea of intravenous injections but I don’t like the idea of a vitrectomy either! A 20% decrease in disease progression might win me enough time (and macula!) to have a more successful intervention later.

If you have dry AMD and geographic atrophy, it might be worth your while to broach the subject of lampalizumab with your retinologist. Let him know you are interested. This could just be the start of something big for all of us.?

Continue reading “BIG News!”

Not Your Parents’ AMD

3 pm Monday and so far it is a good day. The pool guy is working on my new liner. The funny thingee on my tummy is a normal, benign growth and the transportation company got new vans with fancy logos painted on them. No more confusion with two dozen, white vans. Life is looking up!

Lin told me there was a conversation thread in the Facebook group about parents who struggled with AMD. People remember what their mothers and fathers went through and they are determined not to become like them.

I am reasonably sure my father’s vision problems were AMD. The more I think about it his father’s vision problems may have been AMD. I remember both of them using a handheld lens to read the newspaper as well as the really strange interpretations Daddy would have when it came to TV shows. I have no idea what HE was watching but it was not the same thing I was watching!

I have said it a couple of dozen times and I will say it again: this is the best time in the history of the human race to be losing our sight. Absolutely the best. You may not realize it. You may remember what you saw and think we are doomed to go there too but we are not. We really are not.

I tried a handheld magnifier for a couple of weeks. Not doing that again. They are very inefficient. I have my CCTV, my handheld reader and my iPad which can go in the Justand.

[Lin:Linda: To see what Sue uses on a daily basis, check out these pages: A Day in the Life and A Day in the Life:Work Day.]

I can get newspapers on my phone and books from BARD (there are other sources, too, as well as magazines which are available).  I’m able to take a picture of pretty much any text I want and my KNFB Reader will read it to me. The zoom feature on my iPad will allow me to read email and research pretty efficiently. ZoomText allows me to work. (refer to the “Day in the Life” pages above)

If I want to look at something a little distance away I can use my max TV glasses or my monocular. Not too bad.

Depending upon when Lin publishes this page, you either have or will be hearing about audio description services (coming soon!). If my father had had those for the TV we would have been “on the same page” a lot more than we were when we watched programs together. Audio description can also allow you to go to the movies and live theater and actually know what is going on.

Do I want to be losing my sight? Hell, no! This is not a walk in the park but it is not what Daddy endured either. Just the same he made it into his mid 80s and managed to take care of himself until other issues brought him down. If he could do it without all of the toys, I can do it.  [Lin/Linda: My dad had geographic atrophy & took care of my mother who had Alzheimer’s using several different handheld magnifiers & a few other low vision aids.]

Yet another reason to be optimistic is all of the exciting research happening. We are poised for a veritable explosion of treatments. Not cures, mind you, but treatments. Thirty years ago there was nothing.

[Lin/Linda: To see what’s in the research pipeline, click here.]

What can you do? Be willing. Use what has been provided. If you put that iPad your son gave you in the drawer you have absolutely no grounds for complains. Bluntly put? Your extra suffering will be your own damn fault.

What else? Volunteer. Sign up for clinical trials. Join support groups. Share your knowledge and skills.

Life – and this vision loss bit included – is the craziest thing you will ever experience and none of us get out alive. Make the most of it while you can.

Continue reading “Not Your Parents’ AMD”

Mi Depression, Su Depression

We all know adjusting to sight loss is stressful. We are well aware of the times it has freaked us out but how aware are we of the impact our loss has on those around us? How often does anyone notice the stress on family members ?

Back in 2009 – that is 8 years ago, guys. Long enough this report could be in the third grade! – there was published an article entitled Family Function and Low Vision: A Systematic Review. The authors lamented they had not had many appropriate articles to review and – guess what – I found pretty much next to nothing since then. Families of the visually impaired are being ignored!

But yet families are a huge support to those who are losing their sight. Adequate support – both practical and emotional – protects against distress and other negative health concerns. The way we stay functional and sane is by having people there for us.

The problem is sometimes family members go through all of the stages of adjustment we do. Shock, denial and mourning are not just for us. But since we are the identified clients, we (hopefully) get the services and the attention. They don’t.

Visual impairment is related to separation and divorce. (Or at least it was in 1993. THAT study is old enough to vote.) There have also been more recent studies on emotion contagion.

Yep, mi depression, su depression*. And if that is not bad enough, the spouses of the visually impaired even have worse physical well-being than controls. Jeez.

The suggestions from the authors were pretty basic: education and mental health counseling. Family members need to know about visual impairment so they know how and how much to help. Overprotection can be nearly as damaging as neglect. Mental health support is pretty self-explanatory. Find and investigate the negative belief systems and see what you can do to refute them. Provide emotional support.

In short, the fight can be as hard on the guy who holds your coat as it is on you. Family members need to know about your vision loss and be told the level of support you need. They need to have time to do things for themselves and they need someone to support them as well. None of this is easy on anybody but it is easier when we do it together.

*translation of title is “My Depression, Your Depression” as in the phrase “Mi Casa, Su Casa” which literally translated means “My House, Your House”.

Continue reading “Mi Depression, Su Depression”

Improving Communication: Part 3

Hello! Rode my bike to the Y. Took a couple of classes and rode home. Then it was dog walk time. Right now I could stand a nap! Hopefully I can stay awake enough to write a sensible page. A little wonky? You know why!

I have continued to look for more information on loneliness and poor, social relationships for the visually impaired. You remember, miscommunication because of lack of nonverbal cues.

[If you have not read Sue’s previous 2 pages, I suggest you do that before continuing.  First, there’s Improving Communication: Part 1, then Improving Communication: Part 2]

The Pocklington review ended up saying there are no current answers. They called for more research. Hopefully the increasing numbers of us visually impaired will encourage someone to get on the proverbial stick.

Once again, there should be some sort of manual for this but I cannot find one. (Back to if you want something done right, do it yourself! Anyone want to make topic suggestions?)

An abstract from work done by Wang and Boerner indicated responses in their study fell into two categories. Sometimes the visually impaired adjusted their behavior while other times they just let the relationship go bad.

The group who tried to maintain relationships depended upon a few different strategies. These strategies included explaining themselves more and being more assertive. They also included relying on other senses for information, faking it and being more selective about whom they interacted with.

Remember several articles I read for both vision and hearing impairment stressed the need to share you have a disability. That can be hard for some people although not admitting to a disability can end up being harder in the long run. Sometimes we just gotta accept.

The people who let relationships go of course did things differently. They would withdraw and make fewer efforts to socialize. They would also become angry and tell people off.

As I research this, I keep coming back to the need for work with a good speech and language therapist to improve communication skills. Or at least that is my conclusion. Once again I could be dead wrong.

Quite a while back an Italian study, Extracting Emotions and Communication Styles from Prosody, included some neat charts that are basically a guide to identifying speaker emotion from prosody. Prosody is the pattern of stresses and intonations in speech. For example, joy is characterized by factors like quick meter, quick attacks and slight or missing vibrato.

If these characteristics have been identified and listed, it means people can be taught to recognize them. And if we can be taught to recognize them, we can harness them in efforts to improve communication which just might lead to fewer feelings of isolation and loneliness. Maybe?

….for what it is worth. That’s what I got. If there is a definitive answer out there, I don’t got it. I can’t find it. Anyone have any other ideas, let us know and we will pass them on.

These three pages were in response to an inquiry from a reader. If she knows one person with these concerns, we suspect there are dozens more lurking in the shadows. By addressing her concerns – or yours- we may help others.

Keep those cards and letters coming!? Continue reading “Improving Communication: Part 3”

Yesterday’s News

Good morning! Lin just shared a video clip from something that looked like a local TV, health program. The clip was on geographic atrophy. That is GA to those in the know.

I have no problem with information being shared with the public. In fact, I think it is a good thing. The more exposure we get and the more noise we make I am hoping two things will happen. One would be law makers (read the deep pockets of government) will be more aware and sympathetic to our plight. (They might also come to realize it is going to cost BIG bucks to care for us!) The other will be people who have AMD will become more knowledgeable and go for help and support.

There are some drawbacks to these little TV presentations, though. For one, they are a bit behind the curve when it comes to breaking new news. The show talked about a fantastic, recent development that would help people with GA.

Fantastic? OK. Helpful? Yep. Recent? Only if you consider research published in 2013 to be recent.   So shoot me. I am an information snob. That information was just too yesterday’s news for me.

I also think they present half information. If you listen to the clip you will hear the expert talk about a ‘subset’ of patients who cannot be helped with current treatments. Not to put too fine a point on this – and look out because I can feel myself getting ready to rant! – but, honey, the group that can be helped with current treatments is the subset! 15% of AMD patients ‘go wet’. The 85% of us who are left are not the subset! (Told you I was going to rant!)

In the clip there is the implication that replacing RPEs will restore sight. We have talked about this a dozen times before. In GA the photoreceptors are dead. There is no sight without photoreceptors. The RPEs are support cells for the photoreceptors. They do not do any of the ‘seeing’.

But my big complaint about this clip? The expert says your world ‘ends’ when you develop GA!!! (Now I am really revving up. Head for the storm cellar!)

With every significant loss, there is a time of dismay and distress. That does not mean the end of your world! Everyone of us here is made of tougher stuff than you could ever have believed. Maybe you have never been tested before, but the steel is there.

Today I taught my class. I attended a staff meeting and saw two clients. Then I came home, walked the dog and made a meal. I am now writing this page. After that I have a psych report to write. Then maybe some down time ‘reading’ a BARD book.

Tomorrow I work, walk with a friend and go to my yoga class. I am making plans to go into New York City with a co-worker next month. The list goes on.

In short, if my world ended a year and a half ago, nobody bothered to tell me about it! I am still going pretty much full tilt!

So, bottom line? I guess it would be listen to the stuff in the media but remember it might not be accurate or current. Once again, caveat emptor. Best sources still remain published research. If you cannot read it or cannot understand it, ask Lin or me to look at it and we can tell you we don’t understand it either!

And about that end of the world business? Don’t believe everything you hear! GA is not a walk in the park. However, if you want to, you can still do that and dozens of other things as well.

Continue reading “Yesterday’s News”

Sisters Are Doin’ It For Themselves

I have paid a lot of attention to the male movers and shakers in vision research. Perhaps it is time to note the contributes of the women. Recently I have come upon short articles about the research of two.

Sally Temple, SUNY-Albany, and her colleagues recently published a paper on how nicotinamide can suppress the progression of AMD. Nicotinamide is a vitamin B3 derivative.

Dr. Temple took pluripotent cells, that is stem cells, from people who had AMD and those who did not. She manipulated the stem cells to become retinal pigmentation epithelial cells and grew them in her lab.

One of the first things Temple and her team noted was the cells from the AMD people acted differently from the RPEs grown from healthy subjects’ cells. The cells from people with AMD produced different chemicals. The chemicals were the same ones that figure in the production of drusen and contribute to inflammation.

These were RPEs growing on a culture medium in a glass dish. There was nothing else to contribute to the formation of the chemicals. The chemicals had to be coming from the RPEs. And, with no other possible influences, the cause for the production of these chemicals pretty much had to be genetic.

The fault, dear readers, is not in ourselves but in our genes. One more tally in the genes are destiny column.

But the good news is, when they squirted (or whatever) nicotinamide on the offending RPEs, things improved. Chemicals that are responsible for the bad things were less and the RPEs survived longer.

Perhaps if we find a way to get nicotinamide directly into eyes, we will get the same results in vivo as in vitro. Worth a try.

Masayo Takahashi is a Japanese researcher. Takahashi has been experimenting using pluripotent cells taken from the same people they are going back into. No embryonic cells required.

There is excitement about this new procedure not only because of ethical issues. There are indications this procedure will be cheaper and faster to implement. In additional, they are thinking people can ‘bank’ their stem cells. These can be used either for ‘repairs’ in the original cell ‘owner’ or they can be given to other people who are immune matched. (Sort of like blood type matching. Don’t want the body getting up in arms over the ‘invading’ materials.)

Bottom line is the ladies are out there rocking it just like the men. They continue to come up with great new findings and each one takes us a little bit closer to effective treatments and maybe – just maybe – even a cure.

To copy Lin’s use of old song titles, “sisters are doing’ it for themselves”. And they are doing it for us, too! Continue reading “Sisters Are Doin’ It For Themselves”

Caveat Emptor

So we have come to the middle of another week. Hump day, Wednesday!

I looked up funny hump day jokes and found a slew. You can take your pick. Some of them are giggle-out-loud quality.

Anyway, I taught today and then went over to the sight loss support group. My low vision person was presenting the latest in low vision technology, the MoJo monocular.

Mojo monocular

I cannot give you much of a spiel on it. I have not done much more than glance through it and pass it on. Therefore, as usual, this is just me telling you what I read. No recommendation.

The MoJo is a magnifier that works both near and far point. The price for the handheld monocular itself is about $1500. Add the part that can turn it into a CCTV and you are looking at $3000 or so. The manufacturer, Enhanced Vision, advertises a large field of view and autofocus capabilities.

This may be a great addition to the list of low vision tools. May not be. The MoJo has only been on the market for two or three months. If you are interested and have the money, try it and give us a product review.

And continuing in the interested and have the money vein, I have started to see articles suggesting that, in spite of its celebrity endorsements in the UK, the Eyemax Mono may still have some bugs to work out. The Daily Mail reported the Macular Society is suggesting caution before you agree to undergo this expensive procedure. The cost being quoted is £15,000 which at present exchange rates is approximately $19,480 (May 2017). Ouch. And if you are an American, remember the Eyemax Mono is not FDA approved and added to that cost would be a trip across the pond.

In short, it sounds promising, but remember caveat emptor. Use extreme caution before committing to any new procedure. Do your homework. Nothing is ever as good as it sounds at first blush.

The newest implant this side of the pond is a miniature telescope. This one is FDA approved so it should be both effective and safe. The manufacturer is VisionCare.  The surgery is Medicare eligible according to the article so we are not talking about huge out of pocket costs. That is a plus.

Now, once more, on the minus side, this is not a cure and will not halt the progression of the disease. All it is is magnification and a spreading of the image to intact parts of the retina. They have moved the magnification system from the outside in.

They also will only do the implant in one eye. That is because there is a ‘tunnel effect’ in the vision of the treated eye. The untreated eye is used for peripheral vision.

Another problem with the telescope is the need to train the brain. There is a period of several weeks during which the patient is learning to adapt to a new way of seeing.

Bottom line, things are progressing but not necessarily in the areas of treatment or cure. All three of these things mentioned magnify and move the image to intact retina. Close, but no cigar.

My personal preference is to find something medical that will stop the disease progression in it’s tracks. Barring that, magnification and relocating the image may bring you an undetermined period of better sight. You pay your money and you take your choice….just do it wisely.

May 10th, 2017 Continue reading “Caveat Emptor”

AMD & Autoimmune Disease – A Connection?

Hello, folks! Here we go again with a topic that is so far over my head I never should have even attempted it. Oh well, one of our readers asked the question. And besides, “a man’s reach should exceed his grasp or what is a heaven for?” (Robert Browning – and one of my favorite quotes?)

So you have again been forewarned. I am slogging through medical research and I have no clue what 90% of what I am reading means. If you get confused, just consider who is doing the interpretation!

The question was: can AMD be considered an autoimmune disease?

The answer is probably, maybe. They are working on that now. Can I get back to you? Like next year, maybe?

I am sure we all remember the alternative pathway of the complementary immune system. ? From what I remember things this system deals with include inflammation and the release of macrophages (big eaters) to clean up the mess. Macrophages are sort of the carrion eaters of your body.

According to webMD inflammation is supposed to protect us from foreign substances. It occurs in response to chemicals and involves an increase of blood flow to the affected area. Fluid leaking into tissues can cause redness and swelling. Swelling can cause damage.

Autoimmune conditions occur when there is no foreign invader and the body starts to identify its own tissues as something foreign. Healthy tissues come under attack.

AMD is an inflammatory disease. It would make sense that with chronic inflammation, the signaling system could easily go awry and result in ‘friendly fire’ casualties. By my way of thinking, this might be even more likely because both inflammation and macrophages are part of the innate immune system. The defenses of the innate immune system deal with nonspecific targets.

Morohoski et al. wrote a paper on autoimmunity in retinal degeneration. He (she? It is K. Morohoski) states “a growing body of evidence indicates that AMD pathogenesis too involves ocular inflammation and autoimmunity.”

But it is not just inflammation and the complementary immune system they are now suspecting. Now they are even suspecting involvement of the adaptive immune system. That is the one in which defenses are ‘made to order’ as opposite to ‘one size fits all’. Think antibodies and developing resistance to a disease; that immune system.

Anyway, now they are thinking damage may cause a breakdown of the blood/ brain barrier – remember the eye is the only part of the brain you can see with the naked eye! – and antibodies may be released into the eye. Some of these are retinal autoantibodies. These are proteins that will attack the retina of the host.

So, in answer to the question: it seems reasonable AMD is an autoimmune disorder. It seems probably that not only is the non-specific, innate immunity system in the mix but the specific, adaptive immune system is involved as well. Is it written in stone? Nope? Are they ready to uncategorically declare AMD an autoimmune disorder? Not yet, but I would predict it is coming. Continue reading “AMD & Autoimmune Disease – A Connection?”

Hindsight is 20/20

Good evening! How are you all?

Lin has noticed I seem to have written soooo many pages they are overwhelming and confusing some people. She feels this is particularly true for some of the newbies who probably feel like they have walked in on the (boring and confusing) middle of a movie. [Lin/Linda: to be clear, those are Sue’s words! ::grin::]

Understood. Some of you are back in the shock and doom phrase and I am talking about getting newspapers on your phones and other trivial matters. Who wants to hear about that sort of thing while your world is unraveling?

In the interest of pointing you towards something that might actually be helpful, Lin is republishing some earlier pages for your attention and discussion. And I – always helpful – am going to add to the confusion by writing another page!?

This page will have a catchy title thanks to Lin, but right now I am going to call it “What I know now that I wish I had known a year and a half ago”.

First, you are not going everything black and dark blind.

It is not good but neither is it quite that bad. You are losing central vision. Things will not be good for anywhere from about 15 to 60 degrees of arc. Since normal visual fields are 170 or so degrees of arc, you have the potential to lose about a third of your vision. Not anything to cheer about but better than 100%.

You may not be doomed to progress to end stage AMD.

About 15% of patients become ‘wet’. About 15% progress to geographic atrophy. That means you – starting out with drusen and a diagnosis of early AMD – have a 85% chance of dodging the proverbial bullet for end stage AMD. You may very well not get as bad as I am and a year and a half after my second eye went to hell, I am still functional. [Lin/Linda: a person can have both wet AMD and geographic atrophy in the same eye.  I don’t what that does to the %, if anything.]

You did not cause this.

Yes, AMD is caused but it was not caused by anything you did or did not do. The causes are in your genes. This is a heritable disease. There are dozens if not hundreds of genes that are being investigated to try to figure out how AMD is created. It appears AMD may just be the result of a genetic ‘perfect storm’ and there is no one to blame.

There may come a time you are seeing things.

I saw some odd stuff when my brain was working overtime to assign meaning to the faulty images my eyes were sending it. You are not psychotic (I hope you are not psychotic). This is Charles Bonnet Syndrome. When your brain gives up trying to assign meaning to false signals you will stop seeing weird ‘stuff’. In the meantime, enjoy the fantasy.

Point number last: There is an amazing amount of hope for treatment and eventually a cure for AMD.

Research is going on everyday. New discoveries are announced with regularity. The medical community is hot on the trail of something that will arrest the progression and may even reverse this disease. All we have to do is hold on.

OK. Those were my biggie when I first lost my second eye. What are you worried about? Please share and we can discuss it. Continue reading “Hindsight is 20/20”

Electrician’s Nightmare

Rods and cones. I learned those words back in the sixties in science class. We were studying the eye.

Rod cells are concentrated in the peripheral sections of the retina. They work well in dim light. They play a key role in night vision. While we need rod cells for good, overall vision, they have their limits. Rod cells are lacking in sharp vision and color perception.

That brings us to the discussion of cones. Cones are located most densely in the center of the eye. Their jobs are to see sharply in bright light and to easily perceive color.

Considering many of us have trouble with sharp, central vision and ‘wash-out’ in bright light, as well as have trouble with color perception, it comes as no surprise that we, those with AMD, are a little short on cone cells. If you have seen images of the ‘divot’ in your macula, that cone-shaped hole should be full of cone cells. Mine is not.

Because we are a bit short on cone cells, cone cells were what researchers were trying to grow for us. After a number of years the breakthrough came at the University of Montreal and was published in 2015. The head researcher was Gilbert Bernier. Merci, Gilbert!

Dr. Bernier came to the idea there must be something that helps to grow all those cone cells in the macula. After all, the embryonic cells are pluripotent. That means they are capable of becoming any one of several different cells. What makes it so these particular cells became cone cells?

Bernier discovered a protein that limited the stem cells to becoming pretty much only cone cells. He actually achieved about 80% purity, a pretty much unheard of accomplishment before this.

Even more exciting, Bernier’s cells organized themselves into nice, pretty sheets of retinal tissue. Not a disorganized mess.

And if that were not enough, when his cells were injected into the eyes of healthy mice, they migrated to exactly where they were supposed to be!!!! Stem cells with the homing instinct! Pretty cool. They were doing the happy dance in Montreal.

This is a huge step but not yet the answer to replacing cone cells, the photoreceptors we lack, and ultimately our vision. As I have said before, the cone cells grown in the lab are like cell phones without a tower. They do what they should do but have no way to send the signal to the brain.

According to the Discovery Eye article on the optic nerve and how it links to the brain, there are approximately 125 million photoreceptors, rods and cones, in the human eye. These connect to two, different intermediate neuron types and 23 different kinds of other retinal ganglion cells. Some of the retinal ganglion cells communicate with as few as five photoreceptors.

In short, the eye would be an electrician’s nightmare! It is no wonder no one has been able to figure it out yet.

There is, however, a way for it to be done. The knowledge of the body – remember these cells both organize themselves and migrate accurately – is miraculous. The next step is finding out how to give the connect order. I suspect the Montreal crew is working on it even now.

Bonne chance, Gilbert, bonne chance. [“Good luck, Gilbert, good luck” for those of us who don’t know French.]

written April 14th, 2017

Continue reading “Electrician’s Nightmare”

Quack, Quack

Caveat emptor! That is Latin for “hold on to your wallet!” (Actually it means “let the buyer beware!” but close enough.)

As of late we have been hearing about ‘medical professionals’ offering services that sound pretty much like quackery.

You know the old saying: if it walks like a duck and quacks like a duck, and looks like a duck, it is probably a duck. The problem is some of us don’t know what one of those old ‘quackers’ looks like.

Ergo, I am offering a short tutorial on identifying the ‘ducks’ among us (Great. Another ‘ornithology’ lesson ?).

You can find dozens – literally dozens; makes me kind of sad about the ethics level in America – of posts talking about how to spot a quack. Skeptical OB gives a shortlist of six red flags that can be applied across the disciplines. They report quacks make claims of secret knowledge and giant conspiracies. They baffle with bullshit and claim they are so revolutionary they threaten the medical establishment. Claiming toxins in everything is a biggie. Also flattery. You have heard it. How you are doing such a great thing and blazing the path for others? Yeah, that one.

There are also posts talking about how to spot quacks in more specific areas. Quackwatch.com has a list of 26 ways to spot vitamin pushers.

Some financial ways of identifying quacks are listed by USA Today. Reputable doctors do not ask for deposits or cash up front. Potential quacks offer the most amazing – and expensive! – treatment first and don’t even bother attempting other treatments. Not covered by insurance? Be suspicious and ask lots of questions.

To support some of the points in the Skeptical OB post, USA Today points out science is pretty much a team sport and very few people make discoveries all by themselves in their garages anymore. Things are just too complicated and too expensive these days.

The idea of the dashing, undaunted, brilliant rogue doing his research alone at night (I just flashed on Dr. Frankenstein here; sorry.) is romantic but obsolete.

Testimonials are great at funerals and ‘roasts’ but anyone who has had to write a recommendation knows such things are easily slanted and misinterpreted. I am stopping short of accusing anyone of outright lies or psychotic delusions, but if all the treatment has to back it is testimonials? Put away the credit card and leave.

The problem – or one of the problems, I should say – with quacks is they go after the vulnerable. Sleazy sons of sea crooks. Are some of us desperate? Absolutely. We don’t want to believe medicine is not yet in a position to help us.

USA Today suggested one of the things I have been harping about now for months: sign up for a clinical trial. Even though ‘mine’ have been stalled for months and driving me insane, mainstream research is where the action – and the hope – is.

Minimally go for a second opinion before you commit to any treatment, but especially if it looks a little murky based on some of the red flags we have talked about. If your treatment provider tries to discourage you, he might be hiding something (like he’s a quack, for example!)

Thus endeth the lesson on ‘foul’ identification?

Be safe out there.

written April 14th, 2017

Continue reading “Quack, Quack”

Preventative Maintenance

Last night I got up to go to the bathroom and I was dizzy, really dizzy. My husband suggested it was my blood pressure so when I got to school I had the nurse check it.

I may not be the gold standard of 120/80 but I was not bad. I hate taking medication but I take it for my blood pressure. As I get older there is not only the possibility of blowing a gasket but there is some (inconclusive) evidence of an association between hypertension and AMD. In any case, I don’t want to make things worse in the eye department.

After being harangued and harassed for years about my blood pressure (part of the reason I have white coat syndrome!) and now taking medication, I was a little dismayed by a medicalxpress.com article reporting there are preliminary findings suggesting some blood pressure meds are associated with much greater risk of developing AMD! What is up with that?

As part of the Beaver Dam studies, they have been collecting data on eyes since 1987. Their data indicated there is a correlation between the use of vasodilators such as some people take for blood pressure and the development of AMD.

Please remember correlation does not mean causality. In other words they could be running together but one is not causing the other. For example, Florida has the largest number of elderly of any state but living in Florida does not make you old.

There are other factors at work. Just the same, something is related between them and we should figure out what it is.

The researchers also found that beta blocker use was associated with increased risk of developing AMD. In particular it was associated with the development of wet AMD. Beta blockers are used for treating heart disease.

Now the article did not say whether the control group also had some form of circulatory system disorder for which they were receiving different treatments. Therefore it is hard to say if it is the medication doing the damage, the underlying, circulatory disease doing the damage or a third factor underlying both the circulatory disease AND the AMD doing the damage. Inquiring minds want to know but we don’t seem to have an answer to that yet.

Because we don’t know, if you are concerned, talk to your doctor and see what he or she has to say before doing anything. Don’t make any drastic changes based on one study. Your doctor is your expert and you should make informed decisions in concert with him.

Me? My high blood pressure meds are diuretics so I don’t need to worry about the meds. However, if I had to guess – and this is a guess from a layperson – my money would be on an underlying genetic snafu wreaking havoc with both our circulatory systems and our eyes.

And until they can lift the genetic hood and make the necessary repairs on that level? Preventive maintenance, my dears, preventive maintenance. Watch what you eat, get your exercise and, yes, take your medication as prescribed.

April 12th, 2017

Continue reading “Preventative Maintenance”

No Kidding!

I pulled a ‘dumb, blind’ chick trick yesterday. I read the time on my phone wrong and was waiting for my ride an hour ahead of time. That was bad enough but when I thought she was late, I got worried about her and started texting her. Pretty sure she was not the one with the problem!

Moral of the story would appear to be you should double-check what you think you know before acting on the ‘information’. Fortunately she thought it was amusing. I decided to laugh, too. Rule 62.

I have finally found time to go to the vision support group run by my low vision specialist. That is tomorrow afternoon. Work is in a temporary (I hope) lull and I could rearrange things a bit.

Not sure how that is going to go. My low vision person had said she wanted me to attend so some people could see you can survive and adapt with vision loss. Not sure I want to be exhibit A. I would like to help but some people get resentful when you try. See how it goes.

We all know the support of others is so important when you lose your sight. I find it sort of amusing – but sad – the medical community is just awakening to that reality. Literally yesterday in real-time, April 10, 2017 they published an article entitled Communication from Doctors Could Reduce Anxiety for Macular Degeneration Patients. Excuse me, but “no shit”. Do you think they joined our Facebook group and figured that one out?

The good folks at Manchester Eye did a study that found large levels of depression and anxiety in people getting shots for wet AMD. No…ahhhh. Never mind.

But don’t you think having a needle stuck in your eye would be a really good reason to be anxious????? Just saying, ya know.

Manchester went on to say there is “value in human interactions between clinician and patient” in offering reassurance about the treatments…..I’ll just bite my tongue and be quiet now.

Better yet, Hugo Senra, clinical psychologist, suggested there is value in specialized counseling with certain patients. All rightee, then. Cognitive behavioral therapy, dialectic behavioral therapy? How about trauma therapy? Not like they are not available most places yet the study indicated 89% of the patients showing anxiety and 91% of the ones showing depression were getting no therapy at all! Someone – actually a large number of someones – appears to be dropping the ball here.

So, yes, it does appear the anxiety and depression you are feeling about your AMD and the treatments really do exist. And yes, we are a grossly underserved population. And yes, we might actually benefit from treatment.

If you are one of those thousands and thousands of underserved folks and want psychological treatment, turn your insurance card over and call the customer service number. They should be able to provide you with a list of therapists who take your insurance. If you have no insurance, call your local mental health agency. In Pennsylvania they are called base service units. Elsewhere I have no clue about the nomenclature but if you search for public mental health providers, they should come up.

In short?……..

AMD? Depressed? Anxious? There is help. No shit. Continue reading “No Kidding!”

Serious Work

ARVO is the Association for Research in Vision and Ophthalmology. According to its website it is the largest and most respected eye and vision organization with over 12,000 members from 75 countries.

Basically, ARVO is hot stuff in the vision world.

The 2017 ARVO conference will be at the Baltimore Convention Center starting May 7. If we don’t get this page published for another four months, the 2018 conference is in Honolulu. We could always go there!?

If you cannot get to Oahu, the ‘Big Island’, for next year, you can always view abstracts of presentations from past ARVO conferences online. There are sections on a variety of eye problems, one of them being retinal concerns.

The first abstract included under retina from 2016 talked about how damaging scar tissue in the eye can be for vision. While anti-VEGF drugs serve to halt the growth of extra blood vessels, they do not prevent the growth of scar tissue. Researchers are working on producing antibodies that will react with the connective tissue growth factor in a protein that contributes to scar tissue formation. This research is still in the (real) rat labs, but may someday be given to wet AMD people with bleeds. Remember bleeds can lead to scars.

The second one mentioned – oops, actually the third – talked about the lack of plasma diagnostic markers for AMD. Plasma diagnostic markers can be found in blood. Someday there may be a blood test that will allow us to determine who is going to start with wet AMD and prevent the growth of new blood vessels even before it starts.

Other abstracts included in the retina section talked about ways of improving ‘bionic eyes’ to provide more details in the images and, yet others, talked about the research being done with stem cells. While the stem cell, clinical trials I am interested in are dry AMD only, there have also been phase 1 clinicals using wet AMD patients. The researcher there, Zheng Qin Yin, reported vision improvement just as was seen in phase 1 clinicals with stem cells and dry AMD. Bonus!

In some studies the stem cell source was embryonic but in other studies they are using bone marrow stem cells. The bone marrow people are also getting promising results.

Never heard of subretinal fibrosis, but apparently someone is studying it! Philipp Roberts to be exact. Not sure why Philipp has two P’s but that is the way he is listed. Anyway……Philipp tells us subretinal fibrosis is the end stage of wet AMD. Apparently you cannot tell the difference between “regular” neovascular tissue and subretinal fibroid tissue with standard imaging techniques. Philipp is working on that.

Basically, there is some serious work being done to hopefully get us out of this mess. I have not said this for a while but I can say it here: now really is the best time in history to be going blind.

And if you are in Baltimore the week of May 7th? Thank a vision researcher for his or her effort. They should be easy to find. The website predicts 11,000 in attendance!

written April 9th, 2017

Continue reading “Serious Work”

Highlight: What foods should I be eating for good eye health?

Nutrition for Good Eye Health – the Basics

Disclaimer

Eye Healthy Nutrients

Click here for a good place to start to learn about aspects of nutrition that have been recommended for good eye health.

 

<–Click on the photo for a larger image.

Click here for more details from AOA (American Optometic Association) about this infographic.

 

 

 

Click here for a printable grocery list.

 

 

 

 

 

 

Diet Plans for Good Eye Health

            • not listed in any particular order; we aren’t making any recommendations & we make no money on the sale of any of the products below.
            • Macular Degeneration Diet and Prevention Plan by Dr. Stuart Richer, OD, PhD, Ocular-Nutrition Laboratory in DVA Medical Center Eye Clinic, North Chicago, IL
            • Eyefoods has a diet plan that you can learn about in their book, on their website, Facebook page or blog
            • Eat For Your Sight Cookbook from the AMDF (American Macular Degeneration Foundation), the cookbook is available here or through amazon.com
            • Mediterranean Diet for eye health
            • Anti-inflammatory Diet
            • Cure AMD, proposed eating plan (based on ‘ancestral diet’) to prevent AMD and reverse it in its early stages.  I’ve corresponded with the author & expressed my concern about his use of the word ‘cure’.  He said he believes so strongly on his research that he could not use any other title.
      • Disclaimer:  We have a standard disclaimer that no one reads ::smile:: so I just want to remind you that we say in it:
        • Any information, books, products or any other materials at My Macular Degeneration  Journal/ey are not intended to treat, diagnose, cure or prevent any disease, disorder or health condition, and is provided for educational purposes only.
        • Always consult your doctor with eye health questions about your specific medical conditions and before starting any diet, exercise, or supplement program.

Go to the Top

Clinical Trial Design: Part 2

Page 2, almost done. Promise.

Types of Variables

Good experiments have independent and dependent variables. The independent variable is the treatment. The dependent variable is the result or what they are measuring.

Again, the idea is to keep as much as possible the same between our two or more groups. The groups are generally treatment(s) and control. Control groups get the sham ‘treatment’. The only things that ideally should be different among the groups are the independent variables, treatments.

In reading a study you can tell what your chances are of getting a treatment by checking how many different treatments they are looking at. For example, if there are three, different quantities of stem cells they are inserting and only one control group, you have a 75% chance of getting a treatment.

The Statistics

After the experiment is done, the researchers do statistical magic and find out if there was a real effect of the treatment. They want to see if what happened could have happened by chance. If there is little chance that it did happen by chance, they are that much closer to finding an effective treatment. At least in the studies I am interested in, people in the control group are offered the effective treatments when the experiments are done. They are not out of luck.

Remember, the medical research we may volunteer for has been done many times on laboratory animals. Unless you are very brave and sign up for a phase 1 clinical trial, other people have had the procedure before you. Real research is published in reputable journals. Ask where their initial findings were published. If you don’t get a decent answer, be very cautious. If you do get a journal reference and cannot interpret it, send it along. I don’t guarantee we will get it right, but we will give it the old, college try.

Size of the study

Also, in research there is such a thing as a cohort. A cohort is a group of subjects going through the same treatment pretty much at the same time. Phase 1 cohorts are small, maybe 7 or 8 people, but phase 2 cohorts may be a couple of dozen people. There are more people in the higher phases. If you are told you are the only one or one of just a few, be suspicious.

Those are some of the things that legitimate research have as well as a couple of extra tips on making sure you are looking at a legitimate study. The information is pretty dry but having access to it is better than falling for a bogus offer and being rendered blind. That is, after all, what we are all trying to avoid!

Just remember, caveat emptor. Check things out very well first. Continue reading “Clinical Trial Design: Part 2”

Clinical Trial Design: Part 1

The Hypothesis

All good experiments start with a hypothesis. A hypothesis is an educated guess about what should happen under a certain set of conditions. For example, “stem cells can grow in the eye and replace worn out RPEs”.

The way I was taught, this statement is then ‘turned around’ to be the negative. “Stem cells cannot grow and replace worn out RPEs”. This ‘turned around’ statement is called the null hypothesis. This is what will or will not be disproven with our experiment. The idea is to see if we can generate a result that will be significantly different from the starting point. The null hypothesis predicts no change. We want to see if we can affect a change that is big enough to matter. Good so far?

The Plan

After deciding what we want to figure out, we need a plan. Our plan is our experimental design. We want to design our experiment so we are reasonably sure there are no stray influences that may have caused the results.

 

The groups

If we are comparing treatments or treatment versus no treatment, we need to make sure our groups are as similar as possible. If we want to see if our new exercise program is better than another training program we really would (ethically) not want 20 year olds in one group and 80 year olds in another.

This is part of the reason good experiments on clinicaltrials.gov list exclusions which means reasons why a person couldn’t be in the trial. They are looking for similar subjects. Another reason for exclusions may be related to the treatments they are using and people’s sensitivities to them. You don’t want a subject who has an allergic reaction to your treatment!

The Sample

Once we have our sample (all possible examples or cases of something is called the population), we should be reasonably sure we have controlled for most of the important variables. Variables are factors that can affect the outcome of our study. However, there are other variables we have to control for in our experimental design.

The Treatments

One of these is the Hawthorne Effect. Anyone who has ever taken intro to psych or industrial/organizational should remember the Hawthorne Effect. In a plant they were trying to increase productivity. The problem became, no matter what they did, production improved! These people could have been working in the dark with the heat turned up to 90F but they were going great guns.

The researchers discovered just the fact that they were noticing the workers and trying to do something for them was enough to increase productivity. It did not matter that working conditions worsened. The workers felt noticed. They wanted to please the researchers.

Placebo effect happens when subjects believe the ‘treatment’ is effective even though it is not. They may show improvement as a result of their belief.

You will see attempted control for the Hawthorne and Placebo Effects in studies that list themselves as ‘double blind’ or ‘double mask’. They will perform fake (sham) procedures on people in the control so they feel noticed and loved, too.

Double blind? The double is because doctors and nurses treat people getting the actual treatment differently. They may not realize it but they may be more encouraging to those actually getting the treatment than they are towards the people who are the controls. When a study is double blind neither the patients nor the people caring for them actually know.

That is my 500+ words for this one. One or two more pages and I should be done. Hang in there!

For more information, click here for Designing Experiments Using the Scientific Method from dummies.com.

Continue reading “Clinical Trial Design: Part 1”

In the News

Real time: March 17, 2017. This Alsatian, Dutch, English, French, German and Welsh girl is, for today, Irish. Happy St. Patrick’s Day!

Patrick was, by historical accounts, a Romanized Brit taken by Irish slavers. Not that the Romans were choirboys. Etymologists say we got the word ‘slave’ due to the proclivity of Roman slave traders to go ‘hunting’ in the Slavic territories.

Anyway, Patrick reportedly had a vision and made his way to the coast where he was rescued. He later returned to Ireland to convert the people to Christianity. The end.

What does this have to do with AMD? Not much. I find it interesting. Knowledge is a good thing.

An informed populace is an empowered populace. An empowered populace is less gullible…and THAT gets me to my topic.

In real time, mid-March, there is a lot of hoopla about a ‘medical practice’ – and I use the term loosely – in Florida being shutdown for blinding three women with a stem cell ‘treatment’. These women also apparently paid top dollar for the ‘privilege’.

Using a lot of quotes here!

First point that absolutely everyone is emphasizing: stem cell therapy for AMD is NOT approved by the Food and Drug Administration.

Therefore, all stem cell therapy is experimental and you should never, ever, EVER have to pay for an experimental treatment. They pay you. Lab rat status, remember?

The studies I am signed up for are through a big, international recognized medical institution. They are being replicated around the world and they are being paid for by multinational corporations. If some backwater, single site clinic is offering AMD stem cell treatments to you for a fee, make your excuses and get out of there.

Not sure how in Hades these people got listed on clinicaltrials.gov. Someone screwed up there. What they were doing was not reported as anywhere near decent, standard experimental procedure.  [Lin/Linda: The clinicaltrials.gov website does have standards by which studies qualify for inclusion on the website but the NIH does not independently verify the scientific validity of each of the studies it lists.  Their answer, which is in the article above about these 3 woman, is that they put a disclaimer with each study.  So, it’s “buyer beware”.)

That said, also the knowledge is power stuff reiterated, I am going to start a short tutorial on what is basic experimental design. I will take several pages to do this so prepare for another mini-series. Consider yourself warned. Take a couple of days off or learn what a real experiment should look like. Your call. Continue reading “In the News”

In a Pig’s Eye

About three hours later and the ‘tapering’ snowstorm is not tapering. Anyone ever read ‘Ghost Story’ by Peter Straub? It scared my socks off on a summer day. On a day like today I would probably be quivering under the covers! [Lin/Linda: this was written in March of 2017.  In ‘real time’ it’s July 2017 when many of us in the US are having record high temperatures. Thinking of snow is ‘refreshing’!]

In ‘Ghost Story’ it starts to snow. They cannot keep the roads open and it snows. The electricity goes out and it snows. The phones go out and it snows. Eventually some smart soul figures out there is a malevolent force at work in this small, New York town. Yipes!

‘Ghost Story’ is on page 3 of the Gs in BARD. It is available as an audiobook on Amazon for $17.95. If you are still able to read print, you can get it used for about ⅕ of that price.

Another way to scare your socks off? ‘Turn of the Screw’ by Henry James. This one is a classic and free on Kindle. It is on page 15 of the Ts in BARD.

I will vouch for them both as excellent reads. Anyone else have any recommendations they would like to share? Just because we cannot see so well, doesn’t mean we cannot enjoy a good book. Since we like to think of our group as a cut above, try to avoid recommending trashy novels.  Although for a whole series of semi-trashy novels I would recommend the ‘….in Death’ series by J.D. Robb, also available on BARD.? [Lin/Linda: one of my favorites, too, but I don’t think I’d call it ‘trashy’ but definitely R-rated.   Click here for the list in order of publication date.  They’re available at amazon.com, too.  Click here for the first one ‘Naked In Death’.]

Anyway, that was NOT the way I was going to start this page. Not the topic either. I just looked outside and found it all a bit surreal. We are approaching an accumulation of two feet. Not much for some other places but impressive for Pennsylvania.

What I was going to do was tell you about “in a pig’s eye” and how the phrase now has a new meaning. For our international friends, “in a pig’s eye” is an old American expression that implies disbelief. It is the antiquated version of “No way!”

Now, they are finding a way to study drusen in a pig’s eye. Well, actually in a culture medium in which they have placed retinal ‘pig’-ment epithelium cells. (Alright, so it was corny, but I couldn’t resist.) They have found out that pig RPEs are similar in many ways to human RPEs. They have discovered the RPEs in early AMD are actually still functioning and the Bruch’s membrane may have more of a part in the process than previously believed.

This should just be the first of many good discoveries to come out of the pig’s eye experiments. Because they are now able to do a lot of manipulations of pig RPEs being grown in cultures, research can go faster. A lot faster than it would go trying to get people to have all these manipulations done on THEIR eyes.

So there is ever increasing hope here. When you tell people there is a bright future for AMD folks and they say “in a pig’s eye!”, your response can now be “Exactly!”

Keep on keeping on. There is hope.

Now could somebody stop this snow? Enough is enough already! Continue reading “In a Pig’s Eye”

Biochemistry Redux

Doxycycline and I have a ‘history’. Not totally a good one. Doxy is the medication given prophylactically when you are bit by a tick. Some doctors recognize waiting for the red ‘bull’s eye’ of Lyme disease before treatment may not be a good idea; others don’t.

The second time I was tick bit I had a doctor that gave me the doxy as a precaution. The first time I was bit I had a doctor who withheld it.

Having some clue of what can happen to a body that has contracted Lyme’s, I was livid. Fortunately – or unfortunately – I had access to about half a vial of veterinary doxy. See it coming?

Do not try this at home! I took the doggie doxy and apparently took a little too much. Doxycycline produces photosensitivity. I won’t bore you with the chemistry (I researched it at the time), but suffice it to say, the molecular structure of doxy is such that it will store light energy and release it over time. You ‘sunburn’ from the inside out! Don’t need a reference for this. This is personal experience talking. I had second degree sunburn in about a half an hour.

The moral of that story is avoid doggy doxy. Once more I am the star of a cautionary tale. Oy vey!

But the reason I even mention doxy and our conflicted relationship is this: Oracea is doxycycline and it is being researched as treatment for geographic atrophy. There may be hope for my relationship with doxy yet!

According to the good people at Medscape (3/12/17) doxy is being researched as a method of treating low-grade inflammation resulting from alternative complementary pathway activity in geographic atrophy.

The alternative complementary immune system in me is ‘the gang that couldn’t shoot straight’. My good cells are being taken out by ‘friendly fire’. Reducing the effects of the alternative complementary immune system in me would be a good thing. [Lin/Linda: Sue’s referring to what she found out from a genetic test she had. Click here to read more about this.]

The Medscape article veers into uncharted waters for me but I will attempt to translate. It appears doxy can interfere with some of the molecular pathways – read series of actions that are supposed to produce something – that end up creating the conditions that lead to geographic atrophy. It lists oxygen species, matrix metalloproteinase, caspase activation, cytokine production and complement activation. Oh, good grief! Social scientist here! Never took biochemistry.

According to Wikipedia, reactive oxygen species are a normal byproduct of the metabolism of oxygen. In times of environmental stress on the cells, levels can build. It ties in with oxidative stress.

Matrix metalloproteinase are enzymes that break down matrix proteins (don’t ask because I don’t know!). Caspases are enzymes having to do with programmed cell death and cytokines are used by cells to send messages to other cells.

Did I mention I am not a biochemist? Don’t understand it except to say it all – magically! – has something to do with causing divots in maculas. Doxy is supposed to, maybe, could be, slow it down.

Clinical trials of doxycycline – under the brand name of Oracea – are underway. Check clinicaltrials.gov for locations near you. I doubt they would give you too much, but just the same, try to stay out of the sun! Continue reading “Biochemistry Redux”

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