Category: Dry AMD

Orphan Drugs

Waiting for the puppygirls to dry before we go in the house. Explain why some dogs will go for a swim and then roll in the dirt. That is one of Etta’s favorite tricks. When the “mudbug” finally dries and I brush her, the dirt flies like it is coming off of Pigpen!

So, on the list today was at least thinking about shampooing the carpet. At this point, I have found the detergent for the shampoo machine. …oh, c’mon! That IS thinking about it! ?

I was going to do it. I really was, but Maggie the Mouth (aka MaggieVox with apologies to the electronics company) decided to have a barking fit at 3 am. Consequently, hubby is napping…good excuse; right?

Good reason for a page!

Number 2 on the Healio list of five top stories for June was about diabetic macular edema so I am skipping number 2 to go to story 3. They have implanted the EyeMax Mono lenses in the first cataract/AMD patient in Argentina.

We talked about the EyeMax Mono in spring 2017. The EyeMax Mono will move the image away from damaged parts of the retina and move it to a healthy location on the peripheral retina. The concept is the same as prism glasses; I think.

Remember neither of the new lenses they are implanting in cataract/AMD patients does a thing to stop the progression of the disease. What they both do is make the effects of the disease be less for a while. Not bad, but not the best I can imagine.

EyeMax Mono has been granted a CE mark in 34 countries. It has been embedded in patients in 25 countries.

The last article with any relevance to us….or at least what I see as relevant to us…is one about a drug for Stargardt’s being granted orphan drug status in Europe. For those just joining us, Stargardt’s is macular degeneration for young people. It proceeds at least generally like dry AMD progresses.

The drug, LBS-008, prevents the build-up of toxins in the eyes. It was granted orphan drug status by the FDA in 2017.

Just to be thorough, let me review the US definition of an orphan drug. According to the FDA’s site Developing Products for Rare Diseases and Conditions, the government provides funding for approved products intended to treat diseases and conditions affecting less than 200,000 people in the USA. Because of the rarity of the conditions they are trying to treat, companies developing these products could not be expected to recover development costs, let alone make a profit. Many of these product lines are abandoned due to cost.

The FDA reported that since the inception of the program in 1983, They have brought over 600 treatments for rare diseases to market. Between 1973 and 1983 the public section brought ten products to market.

And since I am ridiculously curious, I also looked up LBS-008. According to the article Lipofuscin in Dry AMD, LBS-008 tries to reduce Lipofuscin. In my usage, that is eye poop. LBS-008 is supposed to reduce the retinol in circulation, reduce the production of eye poop and lead to a better visual outcome. Once again it sounds like those low bulk dog foods they sold so people would have to pooper-scooper less. However, if it works out, it could be a good thing.

As of 2017, LBS-008 was in phase 1 trials. Remember that is safety and tolerability so they have a long way to go.

I got a long way to go, too. I have not gotten a thing done today. Time to get busy!

Written July 14, 2018

Next: Denizens of the Dry Side

HOme

 

Lights Please!

Lin will be thrilled. After the holiday I am going to work four days a week! No more multiple pages per day![Lin/Linda: You’re going to give these nice people the idea that I don’t LIKE to do your pages! ::grin::]

I have to say I have been easing off on my resolution to spend my ‘retirement’ doing domestic chores. The basement sort of broke my will. Tomorrow we take a load to the dump. Maybe after I get rid of all that, I will be motivated to start again.

In the meantime, there are all sorts of things happening in the world of AMD! Hurrah! Saved again from domestic drudgery!?

Healio ran a little piece saying the EU has granted the Lumithera LT-300 a “CE mark for treating dry AMD.”

Ok. I am clueless.

According to Wellkang Tech Consulting the CE mark – generally made with rounded letters – stands for the French for European Certified. (And no, I am not attempting the French. I was allowed to skip my last reading in my senior year. My accent was so bad, he did not want to listen to me!) It appears this means it satisfies “essential requirements” for a product to be sold in the EU.

Now, supposedly this thing is to offer “a safe and effective early-stage intervention for patients with early-stage AMD.” That makes it sound like it is shelf ready. Coming to a Walmart near you sort of thing. What the hey is it then????

The Healio article says it uses “photobiomodulation which involves noninvasive light-emitting diodes for the treatment of ocular disease.” Wonderful. I love sentences that tell me nothing or at least very little. Good thing I am a helleva researcher even if I say so myself.?

I followed a link to a 2016 Healio article talking about the LT-300 in clinical trials. Get to that in a sec’. Photobiomodulation is first.

Photobiomodulation, according to the American Society for Laser Medicine and Surgery, is a term used to describe the mechanistic/scientific basis for this photonic specialty and photobiomodulation therapy is the term for its therapeutic application. Yeah. The mud thickens.

Moving on, it looks like the category includes lasers, LED lights, and any form of non-ionising light. It appears light energy is being used to alter cells at the molecular level.

What I am looking at here is crossing my eyes, but my ignorant, social scientist guess on this is they are using light to alter cell functioning and, among possibly other things, reduce inflammation. The articles I was scanning mentioned red light several times. My mind immediately went to how blue light is bad for us, and how red light is at the other end of the spectrum. ROY G BIV, remember? [ROY G BIV = Red Orange Yellow Green Blue Indigo Violet]

Here is the disclaimer: I do not know what I am talking about here. That last paragraph was all ignorant supposition based on few facts. I don’t know. If you know something about this, speak up! I could use the help. I said I am a good researcher, not that I understand what I find.?

The 2016 Healio article, photobiomodulation improves visual acuity…suggested the red, yellow and infrared lights used in the study improved visual acuity and contrast sensitivity and – drum roll, please – shrank drusen. They appear to be planning its use with early stage AMD. The idea is to slow the roll to advanced forms of the disease.

There you go. Readers in the EU, go and find out about this thing. This might just be the first treatment for dry AMD. Wow.

Written June 26th, 2018

Next: Pushing the Envelope

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Lookout

This has been day 2 of the partial retirement adventure. I don’t count the weekend. I took the puppygirls to the dog park today. They had not been since they were baby puppies.

Even though there was only one other dog there, they had a great time. Smellfest-2018! They are anxious to go back soon

I got my loaner CCTV set up. The machine itself is not only large but the lowest magnification is HUGE. Better than nothing, though.

I also contacted Eschenbach about repairs. They are really tightening up. Not only no more loaner machines but also you need a credit card on file to get service. No shipping and handling costs paid either.

I got the puppygirls out to the pool this afternoon. Took a look at the pool deck and thought it would be a perfect way to describe geographic atrophy.

What am I talking about? Well, a few years back my husband painted the concrete around the pool. Apparently, his family has something against naked concrete. Anyway, a back injury and my complaining the pool deck looked like it had the mange made him decide not to try to paint again. Being fanciful, I see all sorts of ‘maps’ in the peeling paint. The way the paint is peeling is similar to how your macula is degenerating with geographic atrophy. Patches here and there.

Just a thought. A weird one, but a thought.

And thoughts lead to intelligence which leads to artificial intelligence which leads to a new topic. Tada!

Watch out Microsoft! Google is nipping at your heels!

The Macular Society ran a post about how Google is launching a new Android app. This app, called Lookout, hopes to give Microsoft’s Seeing AI a run for its money. Lookout is reported to be able to do for Android users what Seeing AI does for Apple users. Only they hope to do it better, of course.

Lookout is reported to give auditory cues to what the VIP may meet in his environment. It is designed to wear on a lanyard around the neck or in a shirt pocket.

Lookout is supposed to process things in the environment and share what it believes to be relevant. Sounds like a pretty big order to me!

Supposedly Lookout is programmed to learn what your tastes are and point out to you things that match those tastes. Great as long as you don’t want to experience anything new. It sort of sounds like if the Italian restaurant is next door to the Indian restaurant, Lookout will always steer you in the direction you usually go. In my case, I would be eating a lot of Italian even if I were interested in a culinary adventure. I might not even know the Indian restaurant is there.

Not sure that is the way it is going to work but that could be a problem.

Lookout is again said to have four modes: home, work, and play, scan and experimental. Scan is supposed to have a text to speech feature. Thus, it can read to you.

So, there you have it. Blow by blow of my second ‘work day’ off the job. But don’t worry, you’re going to get a reprieve. I work at the counseling center tomorrow!

Hi ho, hi ho, it’s off to work I go!

Written June 12th, 2018

Next: My New Luggage

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Brighter Every Day

Greetings from what appears to be Pennsylvania’s version of monsoon season. Good grief. Tis wet out there!

This is going to be yet another hodge podge of unrelated ‘stuff’. Bear with me if you can.

First of all, I want to thank all of the kind people in the world and encourage you, if you are not going out because of fear of the stigma of vision loss or whatever, to get out there. Remember I told you I got left the other week? Strangers at the Y who saw that debacle are now checking on me. Do I have a ride? Be sure to say something if I get stuck again.

The clerk at a chain, sandwich restaurant gave me my change in $1s when I said I was visually impaired and needed singles for the van. 18 of them. Bless him.

Then there are my high school friends who drove 80 miles to have lunch and ‘catch up’ and the woman at Zumba who volunteered to give me a ride to Mom Prom and a dozen other people who look out for me and drive my sorry self around. Thank you!

Really. The more you get out there the better life will be. People are basically good and helpful. They will look out for you.

And in other news, I got lifetime dog licenses for the puppygirls. They offer a cut rate to the elderly and/or disabled. It should be about half of what I would have paid if I had bought licenses for the next 13 years. Saving money is a good thing. If you have younger dogs check it out.

NFB Newsline is expanding their offerings. They are now offering a children’s magazine, Stone Soup, as well as Sports Illustrated Online. These are in addition to Sporting News, Globe’s Israel and Science X, not to forget Medical Xpress and the newspaper Concord Monitor.

Remember Newsline comes to you through your phone, including landlines for people who don’t like their electronics to be ‘smart’. They offer a wide variety of local newspapers and you just may find some local news to listen to with your morning cup of coffee.

What else? Well, I found a healio.com article that talked about using immunosuppressants more frequently in Ophthalmology. This April 14, 2018 article did not mention AMD as a target condition, but given that AMD is thought to be related to immune system problems, they may want to look at the utility of immunosuppressants sometime down the line. My point in mentioning it was to show research in Ophthalmology is branching out in many different ways.

And case in point, remember the gene therapy for Leber congenital amaurosis that was developed in Philly and approved by the FDA? The really expensive one, Luxterna? The doctors at Bascom Palmer just injected Luxterna into the eye of a nine year old. His family is starting to see improved functional vision in this child. [Lin/Linda: actually, this March 23rd article says that there were 2 boys who were injected with Luxterna.]

And one more before I go: retinitis pigmentosa is a retina degeneration disease that leads eventually to total blindness. GenSight has gotten MHPRA approval to run clinical trials of gene therapy for RP in the UK. (Alphabet soup, anyone??) Why get excited about that in an AMD blog? To quote the GenSight CEO “If proven safe and effective, this therapy could be transferable from retinitis pigmentosa to dry AMD.”  [MHPRA stands for Medicines and Healthcare Regulatory Agency and is the UK’s equivalent to the US’s FDA.]

Oh! That’s a good reason! Things are looking brighter every day!

Next:  I Got This

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Picturing AMD

Morning! A week past Easter already! Wow, time does seem to fly! Maybe I will research time perception one of these years.

This page is going to be odds and ends again. A couple of things have come past me. First of all, my March Macular Degeneration Partnership newsletter has been sitting in my email for a while. When I looked at it, the first article was on a very small ‘n’ study (6 people) concerning the accuracy of the AMD example photo published by NIH. I would suspect you have seen the photo of the two little boys and the balls. When modified to be what we are ‘supposed’ to be seeing, the photo had a big, gray blob in the center and blurry periphery.

It would appear NIH never asked any of us what we actually see. The arrogance of expertise, perhaps? (Did I say that? So judgmental! Ouch.)

It turns out when six of us were asked, they got six different versions of what AMD folks see. The pictures are in the article. There is only one, apparently a person who had quite the catastrophic bleed, who had a big, black spot. No gray spots with blurs outside of that.

So, I propose a little experiment: let’s take a poll and see which one of those photos is closest to what each of us sees. I am closest to G.

If we get more than six people I will write it up. I suspect the Macular Degeneration Partnership would publish for us. We might be able to be published researchers!

And in other news, when I was reading that article on using a membrane to support stem cell-derived RPEs, I came upon this line: The ELM is a structure present in the normal retina and absent in the area of disease in patients with geographic atrophy.

Oh, hell! Something I am supposed to have, have apparently lost and I don’t even know what it is! ELM?

The External Limiting Membrane is also called the Outer Limiting Membrane (OLM). But whatever it is called, it appears those of us with GA “ain’t got it” any more. According to an article on the histology of the eye published by Researchgate, the retinal is divided into ten layers. With my limited knowledge – and remember we are not experts, not doctors. We are just curious people with access to WiFi – it would appear to me the first seven layer starting from the inside are nearly all some sort of neuron or piece of a neuron. The eighth layer is the ELM/OLM and creates a “junction between Muller cells and photoreceptors.” What else does it do? No clue. I looked at a dozen articles and not one said what the primary purpose is. What they all said was degradation of the ELM/OLM layer is predictive of vision loss.

So where we are knowledge-wise appears to be we with GA have lost our ELM/OLM layer which is somehow crucial for good vision. The article about using the polymer membrane to support the transplanted cells suggested their procedure promoted growth of something that resembled the external limiting membrane and that their procedure might “promote restoration of retinal architecture”. So maybe someday we could get it back???? Who knows.

Anybody know anything about this? Anybody have more questions? Still searching here.

“Trust those who seek the truth but doubt those who say they have found it.” – Andre Gide

Next: Brighter Every Day

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Different Paths

Good morning! I promised myself I would be productive today. Bedding stripped and in the washer, dishes in the dishwasher, a good pancake breakfast in my tummy, now if this webinar would load I might be able to DO something!

Speaking of pancakes, I was taught to flip the pancake when the bubbles are coming up in the middle. Visual cue. I burnt a couple today because I did not catch the little bubbles.

Short of singeing my nose on the griddle, how do I know when my pancake is ready to turn? Any low vision cooking suggestions? Inquiring minds want to know.

Moving right along, I happened upon a 2015 article in Drug Discovery and Development (DD&D) magazine. The article is a bit dated which actually goes to prove the point: research is advancing incredibly fast. Besides remarking that a Nobel laureate, Sir John Gurdon, called RPE replacement one of the most successful stem cell treatments in existence at that time, the article also talked about how regulatory agencies such as the Food and Drug Administration in the States and the Medicine and Health Care Products Regulatory Agency (MHRA) in the UK needed to get up to speed in the area of stem cells.

The article tells a cautionary tale about how the company Geron tried to get the first ES-cell clinical trial approved back in 1998. Their request and justification document ended up being 22,500 pages long and the approval came in – ready for this? – 2009! Good grief. The point is not that the FDA is an obstructionist organization. The point is stem cell science was an ostrich and they were used to dealing with elephants. Nothing fit their paradigms and they had no knowledge about it all.

Pete Coffey of the London Project to Cure Blindness told his own, mini horror story. He had two regulatory agencies to deal with. His wait was one year. Once again his ‘ostrich’ did not fit a system set up to deal with elephants. But kudos to the MHRA. They were not so hidebound that they could not adapt and modify.

The recent, controversial study published by Coffey, et al., was also discussed a bit in the DD&D article. After battling with the regulatory agencies and having his sponsor bail because of no fault of his own, Coffey expressed optimism that, essentially, the worst was over and his research would be moving on. In fact, there are rumors coming out of the UK that they may already be preparing for the next leg of this research. (Remember Lin has spies and secret agents everywhere.)

The article goes on to compare some of the different paths that stem cell treatment of AMD is following. Coffey used stem cells in people with wet AMD early in their disease progression. Work in the States is using stem cells in patients with geographic atrophy. In other words here we are treating after major damage has been done. Coffey and several others have started to be critical of the approach being taken in the US. Are we not at a point now we can pretty much trust the stem cell treatment? Must we wait until so late in disease progression? [Lin/Linda: click here for an article that talks about both the UK stem cell and the US stem cell trials results.]

The other comparison Coffey made was between simple injection of stem cells into the appropriate place and the use of a membrane to give structure to the cells. Coffey supports the latter approach….but that is the topic of an article Lin just sent me. Later!

Written April 7th, 2018

Next: The Patch

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No Respect

Anybody remember Rodney Dangerfield?   His catchphrase was “I get no respect”.

Although I have at times thought that dry AMD was being treated as the proverbial red-headed stepchild, I have always tried to talk myself out of that attitude. The people with wet have real problems. They are one bleed away from blindness. It makes sense they would work for a cure for them first.

However, I finally found someone who at least in part shares my concern. Philip Rosenfeld  down at Bascom-Palmer feels the same way. He doesn’t think dry AMD gets any respect either!

Rosenfeld talked about how all of the clinical research seems to have been focused on wet AMD. However, the truth of the matter is good responders to Anti-VEGF and dry AMD folks alike just keep getting blinder. Rosenfeld remarked how atrophy after ‘eye shots’ and dry AMD has become the most common causes of vision loss from AMD.

Rosenfeld – bless him! – goes on to say the effects of dry AMD are  ‘underappreciated’. Go, Philip! You tell ’em, buddy!

The functional vision loss associated with macular atrophy can be devastating. Okay, so we don’t have these dramatic crises like the wet people but that doesn’t mean we are not suffering. Dry AMD folks have feelings, too.

In addition Rosenfeld goes on to say the proof that dry AMD – and I quote – “never got the respect it deserved” can be found in the International Classification of Disease codes. Dry AMD was seen as so unimportant that there were  no subclassifications.  That is sort of like saying cancer without assigning a type or a stage.  Does the patient have stage 1 skin cancer and we remove the offending spot in the dermatology office or is it stage 4 bone cancer?  Doesn’t matter. It is just cancer.

Once again Rosenfeld notes the societal impact slowing macular atrophy will have. He remarked that vision loss has real impact on quality of life and it is much more than reading letters on an eye chart.

For example, I could not read the forms given to me at the veterinarian’s yesterday. I asked for help. (In case you did not notice, I am trying to be a good role model here. Do ask for help!) Multiple the three minutes the clerk took to help me by 1,000. How about 10,000? That is 500 man hours the people who are helping us could be doing other things!  Good grief.

Rosenfeld then went on to talk about how it has finally dawned on some researchers that we really may be having – and causing – some real problems.  Enter the studies they are now trying to slow the progress of dry AMD.

Lampalizumab looked promising but died in the stretch. Horse racing idiom there.

APL2 is getting a lot of hype. Just the same, there are concerns. As we saw, some people who saw the PowerPoint presentation on the drug  decided “this horse is lame”. (Coming from my heritage, I prefer “that dog don’t hunt” but the idea is the same and I really did not want to mix my references ?) [Sue wrote about this in her page Another $64,000 Question.]

Rosenfeld opined that failure of APL2 to produce any substantive functional vision differences may lead to the question of when to intervene with dry AMD. Rosenfeld seemed to suggest early intervention may be better than late.

Me? I am with Rosenfeld. We know where this stuff leads. There is no question of the potential endpoint. I say nip it in the bud! Treat early!

But who am I? Just somebody with a disease that gets no respect.

Written April 1st, 2018 Continue reading “No Respect”

What’s the Difference?

Hello. Spent a good part of yesterday working on getting my Wi-Fi connection back. My friend says she enlists the aid of the archangels and the saints. Supposedly Hilarion is the patron saint of technology. How a guy who, according to Wikipedia, spent his life wandering in the desert has anything to do with my Wi-Fi is beyond me. Of course, Hilarion sounds like hilarious and tech and I are a cosmic joke….

But before things went dark, Lin sent me a list of things the Facebook members thought would be of concern for those newly diagnosed. At the top of the list was the difference between dry and wet AMD.

I am going to tackle this sans references because, well, I think I got it. But, if I don’t, feel free to call me on it.

To begin with, both dry and wet AMD start out as dry. With the drusen accumulating between your retinal pigment epithelial cells and their food source, the RPEs start to die.

http://patient.info/health/age-related-macular-degeneration-leaflet

RPEs? Those are the servant cells to the photoreceptors. The photoreceptors are the cells that change light energy into chemical energy and then into electrical energy so your brain can see. Without their servant cells, photoreceptors died.

The death of cells and withering of a body part is called atrophy. In advanced dry AMD that is pretty much all that happens. RPEs die. Photoreceptors die and we loose part of our vision. Advanced dry AMD is called geographic atrophy (GA) because the pattern of living and dead retinal cells once looked to someone like oceans and continents on a map.

That is GA. It is generally a slow process. Vision loss is mild to moderate. In my inelegant terminology, your macula just sort of rots away. Yippee.

Now, that is not exactly what happens when you develop wet AMD. In wet AMD, the way I conceptualize it, your RPEs and photoreceptors send out messages begging for more supplies. Excuse me! We are dying here! The body responds by building more supply routes. These are blood vessels. However, these new vessels are substandard products and they leak. Those of us with wet AMD have eye bleeds.

Wet AMD is clinically called neovascular. Neo for new and vascular for blood vessels.

Bleeding in and about the retina causes cell death. You lose cells and vision quickly. One of the commandments of AMD is thou shalt not ignore an eye bleed! Wet AMD only happens in about 10% of us but it accounts for about 90% of the severe vision loss in AMD.

Now, treatments. The short answer for dry AMD is there are none. They are getting closer and I am hopefully but right now the answer is still none.

The AREDS/AREDS2 formula has been proven effective in reducing the rate of progression from dry to wet. Ask Lin. She is our expert. AREDS as a topic makes my head hurt. To my knowledge supplements do little to stop the slow progression of dry AMD. [Lin/Linda here: I’ve put some information about this at the end.]

The treatment for wet AMD is anti-VEG-F shots. VEG-F is the chemical messenger that calls for new blood vessels. Shut that guy up and there is less that can bleed. There are several different types of “eye shots”. Some work better for some people. Others work better for other people. Work with your doctors on that.

That is the difference between dry and wet AMD according to me. Hope it helped.

Written March 13th, 2018

For more information, here’s a good place to go: The Science of AMD.  I highly recommend the 2 videos on this page as well as the other information.

Lin/Linda: OK, more about AREDS/AREDS2.  The short answer is that they HAVE been shown to be effective in reducing the risk of wet AMD but only for those with intermediate dry AMD or advanced wet or dry AMD in one eye but not the other.  There is an issue about one’s genetic makeup in regard to taking the high dose of zinc in the original formulation (80mg).  For some people with a specific genetic marker, taking that much zinc can cause one’s AMD to progress FASTER to wet than those without that marker.  More about this at AREDS/AREDS2: A Guide where you can get more about the short answer, a link to a page where there’s “If you have…” which will tell you if the AREDS/AREDS2 supplements have been studied or not for the stage of your eyes & whether they’ve helped, and a link to 6 pages with details about the research that produced these supplements.]

Continue reading “What’s the Difference?”

Supplies are Limited, So Act Now!

I tend to be pretty optimistic. I have said a couple of dozen times that this is the best time in history to be going blind and I stand by that. Because, you know what? It is only getting better!

A recent piece in healio featured APL-2. APL-2 met expectations in phase 2 clinical trials (proof of concept) and is rounding the base headed into phase 3. Go, APL-2!

Results of the phase 2 trials were, obviously, promising. There was a 29% reduction in the rate of growth of geographic atrophy lesions when APL-2 was administered monthly.

It is possible within a year or so dry AMD will no longer be considered a disease with no treatment. In other words, there will be a lot more hope.

Now granted, these treatments are not cures. But they are better than nothing. Nothing being pretty much what we have now. Would you prefer to go blind in 7.5 years or so without the treatment or in 9 or 10 years with the treatment? Yep. Thought so.

Admittedly, some subjects developed wet AMD with the treatment. Nasty side effect but they will work on that. It did not happen to a large number of folks.

As I have also said before, discoveries build on what came before. The APL-2 study targeted the C3 complement factor and got results. This lends further credence to the theory AMD is a function of the complement immunity system. There is now a strong suggestion we have the right target. There will soon be other treatments ‘leveled’ at that target. More progress will be made.

Phase 3 studies are to start sometime in 2018. According to the Apellis announcement they will be recruiting 1,200 subjects divided among several locations. I looked at clinicaltrials.gov but there is nothing yet listed. Be sure to watch that site for developments. Also, talk to your retinologist about getting into the study pretty dang soon. Lin told me one of the face book members has already been approached by her doctor. There are only 1,200 slots. “Supplies are limited, so act now!”?

Lin/Linda: Since sue wrote this page there has been additional, potentially contradictory information come to light. As usual, we would ask you to gather all necessary information for yourself and make an informed choice on any treatment. We are only one of many sources. And us? We have a few leads and will be following up on the contradictory information. Lin and Sue, girl detectives at your service! Stay tuned and if you have any clues, please share.

And if you want to advance scientific knowledge without subjecting yourself to an experimental treatment, the NEI is looking for subjects for a natural history study. Several measures will be taken, including genetic testing. They will be documenting the natural development of AMD and seeing if they can see any patterns and/or relationships. Not the type of study that will actually treat its subjects, but if you are needle phobic, it might be for you. Remember, Sun Tzu said if you know your enemy and you know yourself you do not have to fear the battle. This study, also discussed in healio, is being designed to let us know the enemy. Knowing yourself is your own problem!

So that is that for now. Hope you are staying positive. This really is the best time in history to be going blind!

Written March 3rd, 2018 Continue reading “Supplies are Limited, So Act Now!”

Advanced AMD (wet or geographic atrophy) in both eyes

Advanced AMD (wet or geographic atrophy) in both eyes

No one with this combination was included in either AREDS or AREDS2.   Some doctors tell their patients with geographic atrophy (advanced dry AMD) in one or both eyes to take the supplement to prevent their eyes from progressing to wet AMD (it’s possible to have geographic atrophy AND wet AMD).

Notes
  • Stages: In order to simplify the results of these studies, we have ‘stretched’ the stage assignments from how they were actually done in the studies.  For example, in AREDS, they looked at the lead/most advanced eye & assigned the participant that stage.  So someone with one eye at the intermediate stage & the other with no AMD, early AMD or intermediate AMD would be assigned the intermediate stage.  AREDS2 used a slightly different method.
  • Source of supplements: There are many ‘eye vitamins’ sold as AREDS or AREDS2 but they do not all have the exact ingredients that were a result of the extensive AREDS & AREDS2 research (see References section below for full study articles).
  • Importance of reading the labels: The ingredients & dosages from AREDS were antioxidants 400 IUs of Vitamin E, 500 mg of Vitamin C and 15 mg beta carotene.  Beta carotene was found to be linked to lung cancer in smokers so for that and other reasons, AREDS2 removed the beta carotene & used 10 mg Lutein and 2 mg Zeaxanthin.  The formulations from both studies included zinc (because of zinc, copper was also included), 80 mg in AREDS and both 80 mg and 25 mg zinc in AREDS2.   It was these exact ingredients that produced positive results (“showed reduction of risk  of developing advanced AMD”) so read the labels of any products carefully to make sure they match the study formulation as closely as possible.  There are 2 webpages in References below that compare selected products.
  • Warning about zinc: Several years ago, warnings were issued about the high dose of zinc in the study formulations (80mg). Those warnings were confirmed by 2018 research that found that 15% of patients with a specific combination of genetic risk variants nearly tripled their risk of developing wet AMD when treated with the AREDS formulation with 80mg zinc instead of a placebo.  For more information about genetic testing, see References below.
References

Go back to The Guide

 

 

Intermediate AMD in one eye/advanced (wet or geographic atrophy) in the other eye

Intermediate AMD in one eye/advanced (wet or geographic atrophy) in the other eye

Studied in AREDS & AREDS2: showed reduction of risk of developing advanced AMD over 5 years.

Notes
  • Stages: In order to simplify the results of these studies, we have ‘stretched’ the stage assignments from how they were actually done in the studies.  For example, in AREDS, they looked at the lead/most advanced eye & assigned the participant that stage.  So someone with one eye at the intermediate stage & the other with no AMD, early AMD or intermediate AMD would be assigned the intermediate stage.  AREDS2 used a slightly different method.
  • Source of supplements: There are many ‘eye vitamins’ sold as AREDS or AREDS2 but they do not all have the exact ingredients that were a result of the extensive AREDS & AREDS2 research (see References section below for full study articles).
  • Importance of reading the labels: The ingredients & dosages from AREDS were antioxidants 400 IUs of Vitamin E, 500 mg of Vitamin C and 15 mg beta carotene.  Beta carotene was found to be linked to lung cancer in smokers so for that and other reasons, AREDS2 removed the beta carotene & used 10 mg Lutein and 2 mg Zeaxanthin.  The formulations from both studies included zinc (because of zinc, copper was also included), 80 mg in AREDS and both 80 mg and 25 mg zinc in AREDS2.   It was these exact ingredients that produced positive results (“showed reduction of risk  of developing advanced AMD”) so read the labels of any products carefully to make sure they match the study formulation as closely as possible.  There are 2 webpages in References below that compare selected products.
  • Warning about zinc: Several years ago, warnings were issued about the high dose of zinc in the study formulations (80mg). Those warnings were confirmed by 2018 research that found that 15% of patients with a specific combination of genetic risk variants nearly tripled their risk of developing wet AMD when treated with the AREDS formulation with 80mg zinc instead of a placebo.  For more information about genetic testing, see References below.
References

Intermediate AMD in both eyes

Intermediate AMD in both eyes

Studied in both AREDS & AREDS2: showed reduction of risk of developing advanced AMD over 5 years.

Notes
  • Stages: In order to simplify the results of these studies, we have ‘stretched’ the stage assignments from how they were actually done in the studies.  For example, in AREDS, they looked at the lead/most advanced eye & assigned the participant that stage.  So someone with one eye at the intermediate stage & the other with no AMD, early AMD or intermediate AMD would be assigned the intermediate stage.  AREDS2 used a slightly different method.
  • Source of supplements: There are many ‘eye vitamins’ sold as AREDS or AREDS2 but they do not all have the exact ingredients that were a result of the extensive AREDS & AREDS2 research (see References section below for full study articles).
  • Importance of reading the labels: The ingredients & dosages from AREDS were antioxidants 400 IUs of Vitamin E, 500 mg of Vitamin C and 15 mg beta carotene.  Beta carotene was found to be linked to lung cancer in smokers so for that and other reasons, AREDS2 removed the beta carotene & used 10 mg Lutein and 2 mg Zeaxanthin.  The formulations from both studies included zinc (because of zinc, copper was also included), 80 mg in AREDS and both 80 mg and 25 mg zinc in AREDS2.   It was these exact ingredients that produced positive results (“showed reduction of risk  of developing advanced AMD”) so read the labels of any products carefully to make sure they match the study formulation as closely as possible.  There are 2 webpages in References below that compare selected products.
  • Warning about zinc: Several years ago, warnings were issued about the high dose of zinc in the study formulations (80mg). Those warnings were confirmed by 2018 research that found that 15% of patients with a specific combination of genetic risk variants nearly tripled their risk of developing wet AMD when treated with the AREDS formulation with 80mg zinc instead of a placebo.  For more information about genetic testing, see References below.
References

Go back to The Guide

Early AMD in one eye/intermediate or advanced (wet or geographic atrophy) in the other eye

Early AMD in one eye/intermediate or advanced (wet or geographic atrophy) in the other eye

AREDS: showed reduction of risk of developing advanced AMD over 5 years.

Notes
  • Stages: In order to simplify the results of these studies, we have ‘stretched’ the stage assignments from how they were actually done in the studies.  For example, in AREDS, they looked at the lead/most advanced eye & assigned the participant that stage.  So someone with one eye at the intermediate stage & the other with no AMD, early AMD or intermediate AMD would be assigned the intermediate stage.  AREDS2 used a slightly different method.
  • Source of supplements: There are many ‘eye vitamins’ sold as AREDS or AREDS2 but they do not all have the exact ingredients that were a result of the extensive AREDS & AREDS2 research (see References section below for full study articles).
  • Importance of reading the labels: The ingredients & dosages from AREDS were antioxidants 400 IUs of Vitamin E, 500 mg of Vitamin C and 15 mg beta carotene.  Beta carotene was found to be linked to lung cancer in smokers so for that and other reasons, AREDS2 removed the beta carotene & used 10 mg Lutein and 2 mg Zeaxanthin.  The formulations from both studies included zinc (because of zinc, copper was also included), 80 mg in AREDS and both 80 mg and 25 mg zinc in AREDS2.   It was these exact ingredients that produced positive results (“showed reduction of risk  of developing advanced AMD”) so read the labels of any products carefully to make sure they match the study formulation as closely as possible.  There are 2 webpages in References below that compare selected products.
  • Warning about zinc: Several years ago, warnings were issued about the high dose of zinc in the study formulations (80mg). Those warnings were confirmed by 2018 research that found that 15% of patients with a specific combination of genetic risk variants nearly tripled their risk of developing wet AMD when treated with the AREDS formulation with 80mg zinc instead of a placebo.  For more information about genetic testing, see References below.

 

References

Early AMD in both eyes

Early AMD in both eyes

Only studied in AREDS. Not enough participants to generate a recommendation. Perhaps results of Awh, Zanke and Kustra (2017) may apply but it has not yet been studied.  The study found that those with a specific genetic makeup may be harmed by taking the antioxidants (no zinc).  See reference below.

There were no participants with early AMD in AREDS2.   Some eye doctors recommend that those with early AMD in both eyes take the AREDS or AREDS2 supplements.  Please make sure that you discuss the benefits versus the risks (ie, interactions with other medications and/or supplements) with your eye doctor.  If you decide to take the supplements, please read the notes below and talk to your medical doctor about them.

  • Stages: In order to simplify the results of these studies, we have ‘stretched’ the stage assignments from how they were actually done in the studies.  For example, in AREDS, they looked at the lead/most advanced eye & assigned the participant that stage.  So someone with one eye at the intermediate stage & the other with no AMD, early AMD or intermediate AMD would be assigned the intermediate stage.  AREDS2 used a slightly different method.
  • Source of supplements: There are many ‘eye vitamins’ sold as AREDS or AREDS2 but they do not all have the exact ingredients that were a result of the extensive AREDS & AREDS2 research (see References section below for full study articles).
  • Importance of reading the labels: The ingredients & dosages from AREDS were antioxidants 400 IUs of Vitamin E, 500 mg of Vitamin C and 15 mg beta carotene.  Beta carotene was found to be linked to lung cancer in smokers so for that and other reasons, AREDS2 removed the beta carotene & used 10 mg Lutein and 2 mg Zeaxanthin.  The formulations from both studies included zinc (because of zinc, copper was also included), 80 mg in AREDS and both 80 mg and 25 mg zinc in AREDS2.   It was these exact ingredients that produced positive results (“showed reduction of risk  of developing advanced AMD”) so read the labels of any products carefully to make sure they match the study formulation as closely as possible.  There are 2 webpages in References below that compare selected products.
  • Warning about zinc: Several years ago, warnings were issued about the high dose of zinc in the study formulations (80mg). Those warnings were confirmed by 2018 research that found that 15% of patients with a specific combination of genetic risk variants nearly tripled their risk of developing wet AMD when treated with the AREDS formulation with 80mg zinc instead of a placebo.  For more information about genetic testing, see References below.
References

Go back to The Guide

Intermediate or advanced (wet or geographic atrophy) in one eye/No AMD the other eye

Intermediate or advanced (wet or geographic atrophy) in one eye/No AMD the other eye

AREDS: showed reduction of risk of developing advanced AMD over 5 years.

Notes
  • Stages: In order to simplify the results of these studies, we have ‘stretched’ the stage assignments from how they were actually done in the studies.  For example, in AREDS, they looked at the lead/most advanced eye & assigned the participant that stage.  So someone with one eye at the intermediate stage & the other with no AMD, early AMD or intermediate AMD would be assigned the intermediate stage.  AREDS2 used a slightly different method.
  • Source of supplements: There are many ‘eye vitamins’ sold as AREDS or AREDS2 but they do not all have the exact ingredients that were a result of the extensive AREDS & AREDS2 research (see References section below for full study articles).
  • Importance of reading the labels: The ingredients & dosages from AREDS were antioxidants 400 IUs of Vitamin E, 500 mg of Vitamin C and 15 mg beta carotene.  Beta carotene was found to be linked to lung cancer in smokers so for that and other reasons, AREDS2 removed the beta carotene & used 10 mg Lutein and 2 mg Zeaxanthin.  The formulations from both studies included zinc (because of zinc, copper was also included), 80 mg in AREDS and both 80 mg and 25 mg zinc in AREDS2.   It was these exact ingredients that produced positive results (“showed reduction of risk  of developing advanced AMD”) so read the labels of any products carefully to make sure they match the study formulation as closely as possible.  There are 2 webpages in References below that compare selected products.
  • Warning about zinc: Several years ago, warnings were issued about the high dose of zinc in the study formulations (80mg). Those warnings were confirmed by 2018 research that found that 15% of patients with a specific combination of genetic risk variants nearly tripled their risk of developing wet AMD when treated with the AREDS formulation with 80mg zinc instead of a placebo.  For more information about genetic testing, see References below.

 

References

Go back to The Guide

No AMD Both Eyes

No AMD Both Eyes

Studied in AREDS only (no participants without AMD were included in AREDS2), participants with this combination were put in a separate part of the clinical trial to study the effect of antioxidants on cataract formation where half got a placebo & half got the antioxidants only (no zinc). The antioxidants are Vitamin C, Vitamin E and Beta Carotene.  In 2017, AREDS data from the cataract part was studied by Awh, Zanke and Kustra (2017) and they concluded that taking these high-dose antioxidants may harm those with a specific genotype.  Because of that, the recommendation from study is to NOT take the AREDS or AREDS2 supplements if you do NOT have AMD.  For more information about genetic testing, see References below.

References

Go back to The Guide

My Advice to Those Newly Diagnosed

Hi! Greetings from Chaos. I need to just sit and chill for a while and since I am not good at doing nothing, I guess I can write a page.

Crazy time! I not only skied Wednesday, I also went to a preschooler’s birthday party on Saturday and a gospel concert today. (Passing on a little bit of good stuff: go onto YouTube and search Sister Rosetta Tharpe “Didn’t It Rain”. The gospel roots of rock and roll. Learned something today!)

Lin said a topic the Facebook group is going to discuss is how to handle “all that bad news” of vision loss. I thought how I would approach that and did some research, but decided to approach the topic from my own perspective first. Then from the perspective of the professionals. And get ready, because I am going to be the naysayer.

What am I talking about? Oh, just what I have been saying for a while now. Specifically this: vision loss is no picnic but it is not as bad as you think it will be. What you are listening to is your fear talking. Stop listening to it!

As I have said before, I was initially told I was going ‘blind’, but I am not. I am losing my central vision, not all my sight. I may be ‘legally blind’ but I do not live in darkness. Huge difference!

The second thing about dry AMD is it is slow. It has been two years, guys, and I am still functional. Remember the commercials about waiting for the ketchup to leave the bottle? That is what it is like. If you have dry AMD, you will not be blind by next Tuesday.  [Lin/Linda here: dry AMD can turn to wet AMD in 10% of those with the disease.  Please make sure you check your vision regularly with an Amsler Grid or another way as recommended by your retinal specialist.]

Bringing me to my third point. A slow-go process like dry AMD leaves you plenty of time to adapt. You will not have to learn how to function as a ‘blind’ person overnight. There will be weeks and months and – yes – years until you will be significantly impaired. There is more than enough time to get yourself adjusted.

What have I given up? Driving. That is pretty much it. Oh, and a lot of reading. I used to read mystery novels. Now I listen to them. A couple of pages to be read can be read with the help of a magnifier.

Don’t panic

What would my advice be to those with a new diagnosis? Don’t panic would be the first thing. You will grieve, of course, but don’t panic. The life changes may be not be as significant as you think.

Take care of your physical health

Beyond that? Advice I would give everyone everywhere. Take care of your physical health. I stay sane by being fit and strong enough to be active in life. I can walk down the road to catch a ride on the street corner if need be. I can carry all my own ‘luggage’ for the day. CCTV, briefcase, lunch, gym clothes all go out with me in the morning. And who is lugging all this stuff? Yep, me. All by my lonesome.

Foster social relationships

I have the best group of people supporting me that you have ever met. People want to keep me involved; bless them. People actually text me and ask if I am ‘good’. They invite me to go along. Get out there. Foster the right attitude. You will meet the best people in the world, too.

Don’t be afraid to do things differently

And lastly, don’t be afraid to do things differently. Learn how to use a CCTV. Apply for BARD and listen to you books. Don’t be so pig-headed and ask for help, for crying out loud!  Lots of problems happen not because of low vision but because we refuse to try a different way.

There it is. Me telling you it is not all the bad news you think it is. Believe me. Revile me. Put me on a pedestal as someone who does amazing things you could never do. But in another few years, when you are functioning just fine as a VIP?  Remember who told you it is going to be okay.

Written 2/21/2018 Continue reading “My Advice to Those Newly Diagnosed”

The Heat is On!

Technically I have a TON of work to do. I brought all sorts of stuff home from the office with good intentions. However, we took the pups to the vet, I satisfied a once-a-month contract I have, we got lunch out, I got a haircut, I took the puppygirls out to run, I went out to cross-country ski in the church field (okay, around in circles but you do what you can when you can’t drive), then I came in and vacuumed, swept and dusted. If it is alright with you, I am done!

Tomorrow is another day. With the things I did today done, I can better concentrate on my other stuff. Right? Hope so, because it really is a crapload of work! I did say no rest for the wicked before; right?

In the meantime, I just wanted to point out how well some other people have been working! Medscape reported that in November a team from Jerusalem and a team from Miami jointly reported great things about the stem cell research they have been doing for dry AMD and Stargardt’s. Their product had passed phases 1 and 2 of the clinical trial with flying colors and is now ready to roll into phase 3. What was really exciting was the report of visual improvement in 18 out of 26 patients.

Now mind you, there was no real control group and the results could be a fluke. However, their star lab rat showed an incredible 38 letter improvement in her treated eye with a loss of two letters in her untreated eye. Not too shabby.

Since Medscape named only the team leaders and not the product, I did a little backwards sleuthing and discovered the head Israeli researcher, Elat Banin, has been working with a product called OpRegen and that is what she presented at the American Academy of Ophthalmology meeting in November. The parent company is BioTime.

According to a press release from BioTime the stem cells are delivered through the subretinal space by “simple intraocular injection”. The cells are “xeno free” meaning there were no animal products used in their production. Immunosuppressants are required for three to four months.

More good news is OpRegen has been granted fast track status by the FDA.  Expedited reviews, etc., should lead to faster release.

Now for the good/bad news. The clinical trials.gov number is nct02286089 and they are recruiting! That is, they are recruiting in Israel and California, specifically Jerusalem, Petah Tikva, Rehovot and Tel Aviv as well as Los Angeles and San Francisco. Not sure what happened to the Bascom-Palmer, Miami, site but you could call and check it out. If you are not in any of those locations you are probably s.o.l. That is the bad news. [Lin/Linda here: ‘s.o.l.’ is short for ‘surely out of luck’! ::grin::]

If you know anyone with advanced, dry AMD who lives in Israel or California, give them a head’s up. They might want to try to become a lab rat.

And we in other areas? Remember this is not just a race between research and our failing eyesight. It is also a race among the drug companies. The one who brings in a viable product first, gets the BIG money. I suspect this news put a fire under more than a few. We can only profit from their singed bums!

The heat is on and great things are happening! This is a the best time in history to be going blind.

Written January 20th, 2018

Continue reading “The Heat is On!”

My New Career?

Not to belabor a point, but today did start as a rather poopy day. We had our first snow overnight. Just a couple of inches but it was the puppygirls’ first snow. My theory is this: when they went out and squatted to poop, they got cold, wet bottoms. Go inside and poop? No cold, wet bottom. Problem solved!

Of course, since my husband was first on scene and got to clean it up, he was NOT a happy camper. Not a good start to the day.

Then there was the snow itself. Getting to my eye appointment is a 90 mile trip one way. My husband does not like city driving and he does not like driving in the snow. Once more he was not a happy camper.

It is hard to explain to some people why we have been dutifully driving 90 miles one way, every six months just to be told my eyes are worse. “Please pay your copay.” For those kind of results, I could go five miles down the road!

However, it is all part of a master plan. I have real problems with defeat. Real problem being told there is no answer. If you cannot supply me with an answer, I will find someone who can!

So here I am, running to see Regillo every six months for the past two years….and I think I am getting closer!

First the good news/bad news. Or, in this case, bad news/good news. Although I find it hard to believe, I have fallen down below 20/400 acuity. Bizarre because I don’t feel blind and don’t think I function as a blind woman.. After all, I got the “you don’t look blind!” routine just last month.

However, the good news on that is my vision is now so bad, I can satisfy the truly awful vision requirement for the Astellas’ study that is supposed to launch in March! Regillo referred me again. Is this time four or time five? I have sincerely lost count. [Lin/Linda: I put the details to that study in Sue’s page The Waiting Game.]

He has also put me on the list for APL-2 which is supposed to go into phase 3 clinicals sometime in 2018. He started to offer me “something else” when we were talking about lamp stuff (which is apparently very dead in the water) and I surprised him by knowing exactly where he was going. Working on being memorable. I want my name at the top of the list. [Lin/Linda: Sue wrote about APL-2 in her page My Friend in Manila?]

Also thinking I may be getting closer because I got a new test today. They ran me on the autofluorescence test. This test uses a very bright light. When the image is examined, the areas of the macula that are already dead are black and the areas that are in distress shine. My eye probably lit up like a Christmas tree. If that gets me into a study and gets this stuff stopped? Good.

So, that is where we are. I got a new test. I chose to be hopeful it means they want more information for my new career as a lab rat! Regillo generally seemed positive. Maybe I will be going to Philadelphia.

Written Dec. 14th, 2017 Continue reading “My New Career?”

I Tried My Best

I was raised to be responsible. I am responsible. I go to work and the job gets done. I have done the job between bouts of vomiting, with fevers and with migraines.

I am responsible but I am not crazy.

OK. Maybe the word is not crazy. However, I am definitely not one for not using good judgment or not looking at the big picture. Now, this is especially true when it comes to my vision.

I was at a professional gathering on Friday. One person there asked me about the circumstances of my sight loss. This person had an eye bleed that had started on Tuesday! That is three, count them, three! days. I advised an immediate trip to an emergency room. I told this person his sight could be very much at risk but was told in turn he had other, important obligations to attend to and he would, essentially, get around to it later.

I tried one more time and was again rebuffed. Are we truly our brother’s keeper? I wanted to call 911 and get this person to the hospital. That would not have been appreciated, but would he have appreciated my efforts if I had saved his sight? If he gets to a doctor sometime next week and gets told he has done irreparable damage to his vision will he appreciate I tried? Will he wish he had listened?

I assume our readers have more common sense, but since assuming can make an ‘ass of u and me’, I am going to spell it out. Never, as in NEVER, ignore an eye bleed. Mary Lowth wrote about vitreous hemorrhages for Patient. She stated vitreous hemorrhages are one of the most common causes of sudden, painless vision loss. Vision can be totally obscured by blood in the vitreous. Even if nothing serious is wrong that caused the bleed to begin with, you can be left with floaters. Not to mention blood is cleared from the vitreous at the rate of only 1% a day. That is over three months of impaired vision!

There is a whole list of things that can be horribly wrong to cause bleeding in the eye. Because I have dry AMD and have been warned about the potential of developing wet AMD, a bleed due to neovascularization was the first thing I thought about. There is also diabetic retinopathy and posterior vitreous detachment. PVD can be associated with a tear in the retina. None of these are problems to take lightly. [Lin/Linda: if you ever see what looks like a curtain drawing over your visual field or part of your visual field is obstructed, that IS an emergency which requires IMMEDIATE attention because it can mean that you do have a retinal tear. Most PVDs are accompanied by lots of floaters & sometimes flashes of light that are more noticeable at night (that’s the vitreous tugging at the retina. If in doubt, call your doctor.]

Lowth stated “retinal detachment must be excluded urgently”. In other words, should you have a bleed, run, don’t walk to the doctor and make sure your retina is still where it is supposed to be. Waiting three days is not an option.

Some of you are also sadly aware that bleeding can cause scarring and even more significant vision loss. Bleeds should be diagnosed and controlled as quickly as possible.

So, there you have it, some people believe they have more important things to do. They believe satisfying responsibilities is more important than taking care of their eye health. These people are wrong. If you even think you have an eye bleed, get to your doctor.

As for this person yesterday, I tried my best. Matthew 10:14 [“And if anyone will not receive you or listen to your words, shake off the dust from your feet when you leave that house or town.”]

written December 3rd, 2017 Continue reading “I Tried My Best”

Diffy Cults

Just getting a quick page or two written before I am off. That is ‘off; as in ‘off on vacation’ not as in “she is a little bit off.” That happened quite a while ago.

Still hoping to get my loaner CCTV before we leave but I doubt it will happened. A friend of my husband’s is watching the house. He promised to take delivery and pack up my machine to send for repairs.

I am still hoping against logic that this will all be settled by the time we get back. Cockeyed optimist; so shoot me.

Of course, I have found several interesting web articles now I don’t have a lot of time to go over them and no CCTV. Since I don’t have my machine to put them on to read, I put one on NaturalReader. Let the iPad read to me. [Lin/Linda: to read all about NaturalReader, go to Sue’s page Let Me Read to You.]

Some of the pronunciations are a bit ‘off’ as well. D.O., doctor of optometry, comes out as ‘odd’. I guess she calls them as she sees ’em!? She? It is a female voice on my machine. Not sure if I could change it if I wanted. Never tried.

Found something called Practical Guidelines for Treatment of AMD. The pamphlet says with all of the rapid advances in potential treatments for AMD it makes it “diffy cult” for practitioners to know what will be “Benny Fish All” to their patients.? Gotta watch those “diffy cults”. Not to mention that Benny Fish All. OK, OK, so I am easily entertained.

The article suggests doctors are not proactive enough in the early stages of the disease. It suggested something like 78% of AMD patients have substantial, irreversible vision loss already at the time of the first treatment. This includes 37% who have become legally blind by the first treatment. Yikes! It goes on to state not all drusen are a result of AMD and doctors may hesitate to make the diagnosis on the criteria of drusen alone. There is also the patient variable involved. Will the patient believe she is losing her sight and do something if there is no acuity loss? Will she freak? Stay tuned….

The article suggests using dark adaptation problems to emphasize there is a real problem even when acuity seems just fine. It quotes statistics dark adaptation is an excellent predictor of age-related macular degeneration and is, indeed, 90% accurate!

In other words, if you know someone who has a lot of problems with dark adaptation, suggest they be checked for AMD. There is evidence problems with dark adaptation can be detected up to three years before the disease can be detected through clinical measures.

Later….There is a lot more in that article, but I have to sign off here. Too much over 500 words and I turn into a pumpkin. Watch out for those “Diffy Cults” and if you run into “Benny Fish All” say hello for me. After all, he is the kind sort. Me, I’m going to crank up my loaner CCTV. It came today!

Written October 27th, 2017 Continue reading “Diffy Cults”

Progress Daily

I really cannot win with this transportation business. Now they are on a string of late pick-ups and I am waltzing in 45 minutes after everyone else. Grrrrrrrrrr!

Oh well, can’t fix it. Time to start a page…..and as soon as I am into it, they will show up. Same concept as going to the bathroom in the restaurant to ‘make’ your meal arrive faster.  Aha! Recognition! You have done that, too!

PRELUDE, the study, is NCT02659098. I checked and this is the same study I put my name in for last year. I just shot off a message to my research contact and asked her to make sure my ‘registration’ is still good. I am nothing if I am not persistent. Sad to say it is one of my better traits (oh no!)

There are actually two, main measurable outcomes they are interested in. There are the efficacy of the delivery system and best corrected acuity after administration of the stem cells. In the clinicaltrials.gov post they refer to the stem cells as CNTO 2476. In other literature they named the stem cells Palucorcel.  I guess it is better than George (with apologies to the royal family. I have never liked the name George, although the little guy is a cutie!) Of course, Palucorcel does not exactly fall trippingly off the tongue.

Anyway, according to a one page write-up by Jessica Lynch, previous attempts to circumvent the vitreous and go in subretinally caused too many problems. They are, as I had been led to believe previously, trying to go around to the macula using the suprachoroidal space as their passage. (Anyone ever see Fantastic Voyage? I keep thinking how incredible it would be to jump in my microscopic submarine and motor through the suprachoroidal space!) After preclinical trials with mini pigs were successful, they launched into prime time with a phase 1 trial with people. As I said, they are now recruiting for phase 2. [Sue wrote about subretinal and suprachoroidal are in the previous page: Secret Passages in the Eyeball

Looking at the additional data on clinical trials.gov I discovered there are secondary outcomes for the study. They will be looking at quality of life and reading speed as well as whether the stem cell transplants slow or even stop the growth of the geographic atrophy. They are also looking at how many people convert to wet AMD. It sounds as if this study would be a long term commitment for the ‘lab rats’ chosen.

Going back to the Medscape article about phase 1, I discovered they had pretty good success threading through the space and the transplanted cells grew and started to function.

Cell placement was important. They used the microperimetry to figure out what retinal areas the subjects were using for eccentric viewing. Too close and that could be messed up. Cell placement other places was better.

Results? The subjects had some improvement in vision. That was SOME. Before you get too excited, remember this is RPE replacement. RPEs do not see. They support your photoreceptors. Some of the photoreceptors that are at death’s door may come back but the dead ones stay dead.

I did run off the journal write-up on phase 1 and I promise to tackle it and see if there were any other cool findings. Later. Right now I have laundry to sort. Maybe listen to an NCIS episode. It is now playing all the way through on my tablet!  What can I say? It really is the little things.

Progress daily, guys. Progress daily. We will get there.

written October 17th, 2017 Continue reading “Progress Daily”

Secret Passages in the Eyeball

Back again. Chatty sort, ain’t I? ? I really thought I was done for awhile but I keep finding things; ya know? If (should I even use the word ‘if’?) you are tired of hearing me chatter, please write a page! We are anxious for more offerings. [Lin/Linda: if you haven’t read the pages by our guest authors, click here to see what we are talking about.]

Back to the topic at hand (I am not only chatty, but I go off on tangents, a lot of tangents??☝ ) the most recent thing to land in my inbox is a Medscape article Lin sent me. We are back to the stem cell research!

This article uses a lot of the concepts and vocabulary we have introduced over the months. I will review as we go along – I don’t remember it all myself! – and Lin might help us out with some links to previous pages. Pretty please and thank you.  [I think the best place to learn about stem cells is a short YouTube video.   Also, check out Sue’s early page Research.]

I am signed up for a Janssen Pharmaceutical study with stem cells. Guess who did this study? Do you ever feel LEFT OUT? Once again, I would love to know how to get on the A list for these things. Not sure all the places the study happened, though. One place was Kentucky. Maybe I was a ‘geographic undesirable’? I will have to do a little research after hip hop. (Some things do take precedence!?)

OK. Here we go. I looked up PRELUDE, etc and got routed to Clinical trials.gov. It is only going into phase 2 but the good news is they are recruiting. The better news is they are recruiting at Mid Atlantic Retina, Regillo’s place. Now I am getting stoked. “Watson!…The game is afoot!”

Shoot off an email later and get ready to accost Regillo when I see him in December. One other person who is only starting to realize the depths of my tenacity! (Cue Vincent Price laughter!)

OK. Enough nonsense….for now?. From the looks of things, PRELUDE was a study checking, for at least one thing, the feasibility of a delivery system. If you recall, we talked about ways of delivering stem cells to the back of the eye where they belong before. No just shooting them into the vitreous fluid where they roll around like loose cannon balls and end up who knows where. No, no, no! They must be placed. The way they are placed is to thread them through the subretinal space.

Now I am thinking the suprachoroidal space and the subretinal space are the same thing but I really don’t know. [The title of the article I linked to above is “Subretinal Delivery of Cells via the Suprachoroidal Space: Janssen Trial”.] How many ‘secret passages’ can an eyeball have? Be that as it may, the whole idea is to snake through this space (or spaces?) and get to the back of the eyeball without violating the integrity of the vitreous and opening it to infection.

The progress of the implanted cells in this study was checked with microperimetry. This appears to be an up and coming imagining technique we also talked about. It is a technique that tests which parts of the retina are working and how well they are actually working.

Which brings me to my word limit and bedtime. I have been to hip hop and back and need to take a bath and get ready for bed.

I did find what I think is the original journal article for this as well as the clinicaltrials.gov listing. I will follow up….tomorrow.

written October 16th, 2017 Continue reading “Secret Passages in the Eyeball”

Eye Poop Reduction

Looking for information on therapies that slow the vision cycle. Got all sorts of things on slowing traffic for safer cycling.

While I am all for fewer car/bicycle accidents, that is not exactly what I had in mind!

Back to Wikipedia, I discovered the visual cycle is the process through which light is transformed into electrical signals. If you have a penchant for chemistry, I refer you to the Wikipedia article. Social scientist here! As far as I am concerned…then there is magic!

Part of this magic includes having three different types of cone cells that respond to three, different wavelengths of light. By taking stock of the strength and blending of the stimuli from these three, types of cone cells, we are able to see color! Cool! Although my guess would have been the primary colors, the colors they detect are actually red, blue and green. Why? Dunno. Magic.

But back on track, visual cycle…

Since the job of RPEs is not only to feed the photoreceptors but also to clean up after them, RPEs have to be able to tolerate a lot of…uh, poop. (Gee, maybe I am just a big RPE! I feel like I deal with that stuff all the time!) When there is too much poop for them to handle, we get, among other problems, drusen.

Janet Sparrow in Therapy for Macular Degeneration: Insight from Acne (catchy title?) said “it is the responsibility of the RPE to internalize the membranous debris discharged daily by the photoreceptor cell.” In other words, they eat eye poop. Unfortunately, some of the molecules in the poop are toxic (as if eating eye poop was not bad enough) and not at all good for the RPEs or surrounding cells.

The theory goes something like this: Less eye poop would make life easier for the RPEs. While we cannot get rid of all the eye poop – after all it is a byproduct of what we want: sight – maybe we can reduce the volume of how much poop we actually have to deal with. If we slow down the chemical processes involved in sight maybe we can produce less poop and thus see for a longer period of time.

They are checking out that theory right now. Foundation Fighting Blindness (FFB) advertised for subjects for a phase 2 (proof of concept) clinical trial of ACU-4429, a “visual cycle modulator”. For our purposes, read “eye poop reduction strategy”.

FFB also published a one page blurb about Fenretinide. Fenretinide has successfully completed phase 2 clinical trials and is on the way to phase 3. They are hopeful it will slow down the visual cycle in those with dry AMD. The slowing should lead to fewer lesions in dry AMD and fewer cases of wet AMD.

Oh, and that chemistry I referred to earlier? I might actually have to understand some of it. Oy. In the visual cycle there is a pigment-y sort of thing called 11-cis. Helping the light signal along its way to become sight causes a chemical change in the 11-cis. In order to get changed back to its original form so it can do its job again and not contribute to the eye poop problem, 11-cis needs help from several molecules, one of which is REP65. REP65. Remember that name. It may be an up-and comer.

written October 14th, 2017 Continue reading “Eye Poop Reduction”

Let It Be

Onward into massive confusion! I may not have the brains to understand this stuff but I make up for it in pure, dogged tenacity.

I looked up peripheral retina atrophy and discovered Eyewiki considers atrophic retinal holes to be full-thickness, retinal breaks generally occurring in the peripheral retina. They are not caused by vitreous adhesions like macular holes. Remember macular holes are caused when the ‘strings’ in the vitreous latch on and tug. The cause for the death of these parts of the peripheral retina is thought to be a failure of blood supply and not drusen or any of the complement factor SNAFUS we may experience in AMD.

So that is one thing I found suggesting peripheral retina atrophy and AMD are not related. HOWEVER, I also found an article suggesting they are and AMD might not be just for maculas any more. Just to make everything more delightful, Ophthalmology in April, 2017 published a study about peripheral retinal changes associated with AMD. (One of the authors for this study was Chew, EY! Beastie Baby would have approved!) Their conclusions were these: peripheral eye changes are more prevalent in eyes with AMD. These changes can be mid-range and/or far periphery of the retina. They decided AMD may be a full eye condition and suggested further study.

Another study done in Croatia and published online in Ophthalmology Retina September 22, 2017 found peripheral drusen, reticular pigment changes and paving stone degeneration occurred more often in those with AMD than in controls. Paving stone degeneration is constituted by small, discrete, rounded areas of loss of pigment and thinning of the retina.

In my limited research nothing said that AMD leads to full retina deterioration. My local retinologist did not say that was the case either.

I am not a doctor and I am groping for answers just like you. Don’t believe a word I say. That said, to clean up the saying a bit, opinions are like tushies. Everyone has one.

This is mine on this topic: Peripheral atrophy and geographic atrophy are probably not the same ‘animal’. There may be some, common underlying mechanism but we don’t know what it is yet. When I was talking to my local doctor he mentioned what might have been the presence of peripheral retinal atrophy in some of the same people who had AMD. Just because they are both present does not mean causality one for the other. He also said he had seen it only rarely and in the very old. Having seen even one case, he was not going to make me any promises things would not go from bad to worse.

Now to my soapbox. I have more than enough to worry about with my macular degeneration and I expect you do too. I am not going to buy trouble. I could waste every minute of every day worrying about a bunch of what-ifs. I have better things to do with my time. I suspect you do, too.

Let it be….
Paul McCartney, 1970

written October 7th, 2017

Continue reading “Let It Be”

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