macular degeneration, macular, diagnosis clinical trials – My Macular Degeneration Journey/Journal

Catching Up – December 2020

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

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

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

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

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

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

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

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

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

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

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

Written December 1st, 2020.

Sue on Assignment: Mitochondria – Part 3

In the interest of full disclosure, I would like to say this: I appear to have screwed up. I could have sworn I read Stealth has gotten FDA fast track status for a phase 1 clinical trial of its mitochondria treatment, elamipretide. Not exactly. It is a phase 2b trial and not a phase 1. Consider this to be my correction and my apology. Mea culpa. Mea culpa. [Lin/Linda: Sorry, Sue, I can’t let you take all the blame. I didn’t catch it, either. Sorry about that.]

According to a Medtran article on clinical trial phases, phase 2a trials are to evaluated the short-term safety of a drug. Sounds like phase 1 redux to me. The phase 2b trial is to start to check the efficacy of the treatment. It is also used to determine dosage range.

The press release Lin sent me appears to be where I initially saw the new drug is injected subcutaneous. That is under the skin. That is that mystery solved.

The dosage schedule is to be daily for 24 weeks. Read six months for that. Zounds. I don’t like the idea of having to go monthly!

I looked up elamipretide + age-related Macular Degeneration on clinicaltrials.gov and got one hit. It was the phase 1 study that was done with 40 people at Duke University in Durham, North Carolina. This study was listed as active, not recruiting. Either phase 1 is not totally finished yet or they have not let the clinical trials.gov people know it is finished.

Looking back on what Stealth published in 2016, I found they were looking for people with intermediate AMD in at least one eye but no geography atrophy or, for a second group, people with noncentral geographic atrophy. An exclusionary factor was having received “eye shots” to prevent blood vessel growth (anti-VEGF treatments.) This study appeared to be totally for those with dry AMD. I am assuming the experimental design and exclusionary criteria for phase 2 will be the same.

It appears information on all of this is rather sparse right now. We will keep our eyes open and see what else we can learn.

And my boo boo? Ahhh, really sorry about that.

Written December 22nd, 2018

Go back to the list of “On Assignment” pages

Send Money

I like to think I get some of this crazy stuff as part of mass mailings and not because someone thinks I am dense, but you never know…

Last week I got a variation on the Nigerian prince letter. You know: “I am a Nigerian prince trying to smuggle millions out of the country. Send me your bank account number and I will wire the funds to you for safety.”  I have gotten that one multiple times.

Last week I got one from ‘The Bank of Canada’ mailed in a Walmart envelope and saying my husband’s grandfather left us $9 million. Send money for processing. Apparently ‘The Bank of Canada’ cannot afford its own stationery!

Then today in my email was an ad with the headline “Your Eye Doctor is Lying to You!” Good grief. How do these people find me?

Just like ‘The Bank of Canada’ using Walmart stationery puts up red flags for me, trash talk advertising does the same. If your product is so great, why do you have to smear someone else?

Then this same email advertisement plays the Higher Power card. The diet they are selling is Bible-based. Eat like the saints and the prophets and apparently our vision problems will be healed.

Playing on the faith of desperate people strikes me as being pretty low. Last time I looked – and I am not a Bible scholar – poverty and charity are biggies in Christianity. Why not just give this diet away?

Again, not a Bible scholar, but the only ‘diet’ I know of that is ‘God approved’ is eating kosher. Check in the Torah for that. Access to those guidelines is free.

So, what is the kvetching about? One, I like to complain. Two, I want to warn you once again to be careful. Immoral, shiftless folks are out there and they are trawling for…us. At least a few of them believe losing sight makes you desperate and stupid. They believe we will try anything. Offer us imaginary money, undermine our faith in our doctors and invoke the name of the Lord just for good measure. That will get them!

If you see an advertisement or are approached about a miracle cure it usually is neither a miracle nor a cure. We are not a consumer protection agency but if you come across something like that, Lin, I or one of Lin’s Facebook people often know something about it already or can find out without a lot of effort. Throw it out to us. Or, actually trust your medical people (and be sure you have medical people you do trust).

Most of us have had a long time to amass some knowledge and common sense. Some people actually would call us wise. (Really?!? Wow.) Don’t let desperation about our vision take that away. If you even suspect a rat, there is probably one close by.

Bringing me to my last quick caveat. We push research and clinicaltrials.gov. After that fiasco in Florida in which three women lost their sight, it came out that clinical trials.gov does not vet the research they list. There are now big disclaimers on their pages. If you are looking there look for big name sponsors and big name research centers. John Smith Labs in Podunk does not make it.

And on that note, I am out of here. Don’t trust any Nigerian princes!

Next: Busy, Busy, Busy – Again!

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The Patch

8:00 pm and I am rewarding myself. I just had a piece of chocolate and I am playing dance music on my iPad. This was the second day in a row I have felt as if I have actually accomplished something. Hallelujah. The to do list is starting to dwindle!

It won’t stay that way. Of course not. I know me. Besides, it is not good to become redundant. Meaning and purpose are like air. We need them to survive. Stay busy!

And on that note, I guess I should stop waxing philosophical and get to work here.

Lin sent me another article. As I alluded to on the last page, this one was about the development of a membrane to support the stem cell-derived RPEs. The research just keeps moving along!

It turns out this new development is coming out of Southern California. Specifically, the University of Southern California, the California Institute of Technology and the University of California at Santa Barbara.

Stop there a minute. University of California at Santa Barbara (UCSB)? Pete Coffey is at UCSB! The good Professor Coffey is co-director of their Molecular, Cellular, and Developmental Biology department. Gee, do you think there could be a connection? ? [Lin/Linda here: Professor Coffey is one of the researchers at Moorfields Eye Hospital in London who conducted the clinical trial that recently made the news with positive results of a similar trial conducted with 2 participants with wet AMD.  He is also Director of the London Project to Cure Blindness.  I found out that he splits his time 50-50 between University College London (UCL) and University of California Santa Barbara (UCSB).  He isn’t directly involved in this study but does collaborate with the UCSB researchers.]

OK. Now it’s time to stop being a smart a** and tell you what they did; right? Right!

What they did was develop a “bioengineered implant consisting of stem cell-derived, mature, polarized retinal pigment epithelial cells in a single layer on an ultrathin synthetic parylene membrane”. Yikes. Let’s ‘unpack’ that as the saying goes.

Wikipedia gives an obscenely long and complicated explanation of bioengineering. You can look at it and figure it out if you wish. The definition in thefreedictionary.com was more simply “the application of engineering principles and technology to the field of biology, especially biomedicine, as in the development of prostheses, biomaterials, and medical devices and instruments.”

We have gone over stem cells quite extensively. We also mentioned that RPEs are polarized but I will go into that a little more deeply. In biology having polarity means the cell has distinct anterior and posterior parts. There is a ‘head’ and a ‘tail’. If they don’t line up right, they don’t work right.

Parylene is a polymer and is ‘green chemistry’. I refer you back to Wikipedia if you are interested in reading more. Social scientist here!

The purpose of putting the stem cell-derived RPEs on a membrane was to support them and and maintain their polarity. The patch was delivered to the back of the eye via the subretinal space (which we have talked about before) during an outpatient surgical procedure.

So how did they do? Apparently pretty well. Bear in mind it was only a phase 1/2a trial and there were only a few subjects, but the ‘patch’ seems to have integrated well and some of the people showed improvement in visual acuity.

For you on the west coast: they are enrolling subjects in six, different locations in California and Arizona. The clinical trial number is NCT02590692. If you are interested, get crackin’! Their numbers will be very small.

Next: Picturing AMD

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“Take This & You’ll Be Cured!”

Good morning! Back again.

I am sure you have noticed that this site has a real emphasis on information and research. We value the power that knowledge can give us. We also value the scientific method.

Some people may ask why that may be. It’s simple. The scientific method and controlled experiments allow us to know with a degree of certainty what is true and what works. Things are proven to within a shadow of a doubt.

Scientific method and scientific proof stand in contrast to anecdotal evidence. I would assume many of you know what anecdotal evidence is. However, for those who do not, allow me to take the podium for a second.

Wikipedia defines anecdotal evidence as evidence collected in a casual or informal manner and relying heavily or entirely on personal testimony. For example, “The world is flat.”

600 years ago everyone knew the world was flat. You look out on the horizon and everything just drops off. Terra incognita. Proceed at your own risk because you know you’re going to fall off. (Did you ever wonder what they thought you were going to fall off into? Just a random thought there.)

It took some intrepid explorers to go out and discover there was something beyond the horizon. They came back and told people just that. However, it was still anecdotal evidence. A handful of crazy sailors telling you that the world was round. It did, in fact, take a variety of explorers taking a variety of voyages (read performing experiments) to actually convince people that the world is round. These explorers proved to within a shadow of a doubt the world was round.

And you know what? I for one am glad people did not necessarily believe that handful of sailors. We should not accept everything without proof.

Very often, this reliance on anecdotal evidence happens in medicine. It happens to people looking for ways to treat their age related macular degeneration.

We hear testimonials all the time. “Take this and you will be cured!”  “It worked for my great aunt Tilly”! That someone truly believes a treatment worked for them is great. However, without scientific evidence we are not able to review it.

Nor should we. Operating on anecdotal evidence can be dangerous. Not only may you hurt yourself doing something dangerous, you could also waste valuable resources – yours and everyone else’s – on something with no value.

Why do we only talk about things that have come from clinical trials? Because the trials are controlled. That means they have tried to eliminate any confounding variables. Confounding variables are things that are outside influences that change the effects of the treatment. In other words with confounding variables we have no idea if what we tried worked. The results could come from something else entirely.

For example, you are going on a diet to lose weight. At the same time you also start walking two miles four days a week and take exercises classes three days a week. How much effect did your new diet exactly have? No way to tell, right? There are confounding variables.

Before we review anything and suggest the treatment may be promising, it needs research backing it up. We operate that way because it is the best way. We need to provide you with the best information we can. The best comes from clinical trials.

Written March 4th, 2018 Continue reading ““Take This & You’ll Be Cured!””

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:

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”

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”

The Waiting Game

Yesterday was my third appointment with Regillo. Quite frankly I was hoping for great things. Hoping I would get a definitive answer and it would be positive! No such luck. My ‘answer’ was another “maybe”.

What criteria are they using? No clue. I was told my eye condition certainly qualifies me. Beyond that, I got no inkling of what I need to do to move up the list.

After a year and a half, I am getting more and more frustrated and antsy. If there is a way to become a prime candidate, I don’t know what it is.

Anatomy of the eye-click on the image for more information

I did learn a few things. Contrary to what I read, the good doctor says everyone has a suprachoroidal space (SCS). [Lin/Linda here: the SCS is the space between the sclera (outer part of eye) and choroid (space below RPEs).  It’s important in both clinical studies Sue is referred to because both insert the stem cells into this space; more about the clinical trials below). Not sure why the difference between what I read and what he said. I know I read something about ‘forcing’ (my term) an SCS in guinea pig eyes. They did it by injecting saline solution between the appropriate layers. Maybe the difference is between having a space and having a medically useful space? I might be wrong but I got the impression the delivery system works better when there is fluid in the SCS. Maybe not. Anyway, everyone has one. I am just not sure if you need the fluid to accommodate the delivery system. If you really want to know, check with your eye doctor. I am still trying to piece this all together.

The next thing I found out was the Ocata/Astellas study may resurrect sooner than I was originally told. I had heard two years or more and now I am being told 2017. Sweet.

I was asked which one I preferred. The one I would prefer is the first one to come to fruition! I will be dancing in the streets to be asked to participate in either one of them.

So that is where I stand now. I have been given two strong maybes. Is that a guarantee I will get something or do two nothings equal nothing? It is driving me crazy!

So back to practicing my distress tolerance skills. I have to ACCEPTS my situation. Engage in activities and contribute to others. I have to compare my situation to those of others and be grateful; things could be worse. Doing things to laugh will help me to have opposite emotions and I can push away problems I cannot solve at present. I can also have pleasant thoughts and intense sensations that distract me from my frustrations. It can be done. I have done it for a year and a half. I can keep on.

written 12/16/2016

Continue reading “The Waiting Game”

Beware Snake Oil

Happy Sunday to you! Lin and I have been emailing back and forth. Since I have another glimmer of hope about the clinical trials, we have been talking stem cells.

I am very optimistic about stem cells. I have known from the instant I saw the Wills studies on clinicaltrials.gov that it was the way I would be going.

I have not wavered in nearly a year and a half and I am not wavering now.

That said, do you remember when I talked about the three states of mind? I try very hard to stay in wise mind on this issue. Wise mind is the melding of emotional mind and reasonable mind. Emotional mind fuels but reasonable mind guides.

Going online we have noticed a lot of what I can only call testimonials to amazing new treatments. These popular press articles all talk about one person – that was one, 1, uno – person who has recovered his or her sight due to this miraculous, revolutionary new procedure, whatever it might be. To me, it seems stem cells have become the new snake oil.

OK. Now some of you just got your hackles up. Calm down. Sometimes snake oil worked. Not saying it did not. However, until it was evaluated pretty thoroughly we did not know a great deal about what it was, what it could do including harm, etc. Lots of harm has been done in the name of treatment.

For example? Blood letting. A president no one ever thinks of, Rush, was killed by bloodletting. It was an acceptable practice. I don’t imagine many of you have had blood removed to cure a disease but I am guessing you may know one person who has. Bloodletting is a proven treatment for Polycythemia Vera, a condition in which there are too many red blood cells. A treatment may have a beneficial use. We just need to find out what that use is. And we need to do it scientifically…at least in my not so humble opinion.

I am cautiously optimistic about stem cells. I have an internationally known doctor at an internationally known facility. The two studies I am signed up for are funded by large, reputable corporations. I even have the informed consent documents already!

What about you? First of all, I would like to think I could influence you to only go someplace with the credentials Wills Eye Hospital has. If that is not possible, ask questions and do your homework without committing to anything. Remember desperate people are vulnerable people. Also, even if the people you are dealing with are decent human beings, their theories or procedures could be faulty or simply not right for you.

What questions to ask? The American Speech, Language and Hearing Association – of all places – published a very nice list (with extensive links; gotta love those speech teachers!) in What to Ask When Evaluating Any Procedure, Product or Program. Read this. Take a copy with you and ask the questions. If you don’t get decent answers, turn around and walk out. Use your desperation, fears, hopes as the fuel but let your reasonable mind do the steering. Stay in wise mind on this one, guys.


Lin/Linda here:  Sue wrote this in December, 2016.  Yesterday (March 16, 2017) an article was published in the New England Journal of Medicine about 3 women who became blind after stem cell injections for which they paid $5,000 from an unnamed clinic in Florida.  The news spread fast and articles were published and widely shared by large news organizations (NPR, CNN, the major TV stations ABC, CBS, and NBC and the New York Times), by macular degeneration organizations (The Macular Degeneration Partnership, Macular Degeneration Association and The Macular Society in the UK) and by several professional organizations for those in the field of vision & eye care.

What went wrong?  This article Three people left blind by Florida clinic’s unproven stem cell therapy says it best from what I’ve read:

  • First there is almost no evidence that the fat/blood stem cell combination the clinic used could help repair the photoreceptor cells in the eye that are attacked in macular degeneration.
  • The clinic charged the women $5,000 for the procedure. Usually in FDA-approved trials the clinical trial sponsor will cover the cost of the therapy being tested.
  • Both eyes were injected at the same time. Most clinical trials would only treat one eye at a time and allow up to 30 days between patients to ensure the approach was safe.
  • Even though the treatment was listed on the clinicaltrials.gov website there is no evidence that this was part of a clinical trial, and certainly not one approved by the Food and Drug Administration (FDA) which regulates stem cell therapies.

 

Continue reading “Beware Snake Oil”

Third Chakra

It seems to be motivation week. The BARD book I was able to find by the second author my nephew suggested is entitled “Drive: The Surprising Truth About What Motivates Us” (No clue. I have not downloaded it yet; it’s also available on amazon.com) Then in yoga my yogini had us concentrating on the third chakra. The third chakra is said to be concerned with a sense of purpose and self-motivation. OK. THEN I was accused of lacking motivation in seeking treatment for my AMD! Really?

I sort of get it. How many diseases can you think of that not only have no cure but no real treatment? (Wear your sunglasses and take your vitamins???? What kind of treatments are they? Where are the pills? The funny machines?)

If people cannot fathom there really is no treatment, how can they understand we are not getting treatment? Not going for treatment? Just obviously unmotivated, we are.

And then you tell them you have been waiting for over a year to get into a clinical trial and they really think you are crazy. Why have you waited that long? You just march right in there and tell them you are going to be included in this! Why aren’t you motivated to get this taken care of?

So, perhaps I have not been forceful enough.  Perhaps they just have not noticed me and they are gathering up more motivated candidates. Perhaps I have my approach all wrong.

I have been asking around and doing my research. I have a fellow yogini who works at a research hospital. Totally unrelated body part, but the ways research progresses should have parallels; right?  She is going to ask about the flow of these things. Are their trial subjects more aggressive? Does it take those researchers forever to get their stuff together and get it on the road? Inquiring minds and all that.

I also went onto that purveyor of all things known, the web and particularly Wikipedia, and looked up recruiting for clinical trials. According to dear, old wiki, the recruiting business is a billion dollar venture. Recruiting is the most time-consuming aspect of research and is responsible for the failure to meet many, many clinical trial deadlines.

All of which begs the question: why are they not calling me? I am certainly not playing hard to get!

All the other materials I turned up on clinical trial recruiting were of the same variety. Those articles talked about the problems finding people who are willing, able and appropriate for participation. While I feel their pain, my problem is the opposite. I want to understand why no one is calling me. Is there a handbook for this somewhere? What is proper etiquette for seeking a position as a lab rat? I have NEVER had this much trouble landing a job!

So, no, I am not unmotivated.  My third chakra is working just fine; thank you. I am playing a game to which I do not know the rules and I am afraid of pushing too hard. People don’t pick shrinking violets but they don’t pick prickly people either. Anybody own an old rule book for this stuff? I could use a little guidance.

Continue reading “Third Chakra”

News: Stem Cell Clinical Trials in the UK

For Those in the UK

Click here for an article about a UK patient at Moorfields Eye Hospital in London as part of The London Project to Cure Blindness.  Click here for the press release dated September 28, 2015, that describes the ongoing project.  The patients in this study have wet AMD.  This is apparently the first study of its type in the UK.

Click here for more information about the stem cell research trials including 2 videos and a graphic illustration of where the stem cells are implanted.

Want to know more about what stem cells are, where they come from, and how they are used?

For more information about stem cell research, click here to read Sue’s page where I’ve placed quite a few links to helpful articles.  There’s also a link to the clinical trials website for the US.

For more information

News: Stem Cell Treatments – Successes, Concerns, US Legislation

 

Resources

June 2023 There’s an announcement that since Sue has not written any new journal pages for some time, the site has been archived until we can decide if the work necessary to make sure all information is accurate and up-to-date can be made. In the meantime, you’ll get some pages ‘not found’ or ‘private’ until that decision has been made. The emphasis for several years has been on the Facebook group.

2/14/2022 Because of the rapid and constant growth of our Facebook group, I cannot keep this list updated.  I have a large amount of information available in the Facebook group in Guides which are like chapters in a book or lessons in a course. Plus, in 3 years, the amount of information in the posts and comments is quite substantial. I recommend that you join us there where you can get the information and the support to help you in your journey.  Thanks for understanding. Hope to see you there! Lin/Linda…
I’ve added some pages from that group that might be of interest to you.

Frequently Asked Questions

Click here for the list of Frequently Asked Questions from our Facebook group.


AREDS2-based Supplements

There are several pages on the site that explain what AREDS2 means and who the AREDS2-based products are for. Click here to go to a list of articles.

AREDS2-based Supplements With 0 or 25mg of Zinc

Click here for the list.


Navigating

There are a lot of links here.  I’ve set up this page so that when you click on a link (words that are underlined & in blue or green), a NEW tab will open in your browser and this page STAYS WHERE IT IS.  When you are done with the new page you opened, just close it.  You do NOT need to use the back option.  If you click on a link and the new page replaces this one, I’VE MADE A MISTAKE so please let me know by sending me an email at light2sight5153@gmail.com.  Let me know exactly which link or links do not open a new tab or window.

Errors: If you click on a link and you get a ‘page not found’ error, please let me know by sending me an email at light2sight5153@gmail.com.  Let me know exactly which link or links do not open a new tab or window.

Additions: If you have a link you’d like to add, please email at light2sight5153@gmail.com.


Topics-click below to move to a topic

Links We Like

  • Click here for a GREAT resource where you answer some simple questions and you get a customized guide based on your responses
  • Click here for a great glossary
  • Click here for Low Vision Resources: A List of Lists (such as 8 ways to slow AMD, 15 tips for family and friends, etc)
  • Videos
    • Click here for several videos
    • Click here for the UK Macular Society’s Say Hello to Mac
    • Click here for one that uses illustrations and animation (explains how wet AMD progresses and how the injections work)
  • Click here for a description of dry vs. wet AMD (we are not recommending any products in this article)
  • Click here for an article about depression after diagnosis
  • Click here for a very comprehensive page about wet AMD
  • Click here for a very comprehensive page about dry AMD
  • Click here for a FAQ (Frequently Asked Questions) that answers a long list of questions such as ‘will resting help my eyes?’, ‘Can I see for myself if my retina or macula shows any signs of damage before I have symptoms?’, ‘why don’t new eye glasses help?’, ‘what is meant by degeneration?’, ‘is a macular hole the same as macular degeneration’, ‘I have had dry MD for years. Does this mean I’m going to get wet MD too?’, ‘No one else in my family has MD. Why did I get it?’, ‘can drusen be treated?’, ‘I have changes on the Amsler Grid, does this mean I have MD’, ‘I have Wet MD but my Doctor says there is nothing he can do or no treatment available. Why is this?’
  • Click here for a short introduction to stems cells, what they are and how they can be used.

See what vision is like at the various stages of AMD

Click here to find ways to see simulations of what vision loss due to AMD is like at various stages.


Glossary

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Websites devoted to AMD and Other Forms of Macular Degeneration

listed in no particular order

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Websites containing information about AMD and Other Forms of Macular Degeneration

listed in no particular order

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Support

I’ve not been able to verify if these are kept up to date. Let me know if you find that they are not or if you have one  you’d like to add.

Message Boards including ones from
By postal mail

I don’t know if these are still accurate.

  • Association for Macular Diseases
    210 E. 64th Street
    New York, NY 10021
    (212) 605-3719
    – Offers education and information on macular disease through seminars, newsletters, and a hotline. Offers counseling to patients and their families.
  • Macular Degeneration International
    is now a part of Foundation Fighting Blindness
    Toll Free Helpline 1-800-683-5555
    EMail: MDInfo@blindness.org
    – Provides support for people affected by inherited macular degeneration including Stargardt’s disease.
Start Your Own
  • Vision Support Group-download video presentations  This group provides free information and support through presentations to groups of senior adults affected by macular degeneration and related retinal diseases.  You can join & get access to their materials so you can use them in your own group.
On the phone/telesupport

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Where to find services

  • In the US: click here to find a low vision center, retina specialist, state agency, ophthalmologist
  • In the UK: click here to support services (listed on the right side of the page) such as skills for seeing, counseling, access to treatment…and more
  • In the US: click here to search for a wide variety of services (more than the link above)
  • In Australia: click here to find an ophthalmologist and optometrist
  • Worldwide: click here for resources worldwide

Resources for Students

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Books and reading materials

Specific Titles

Sources of Books

Formats: Braille, large print, e-book and audiobooks

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Videos

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Personal stories of living with AMD

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Online newsletters

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What is AMD?

Wet Form
Dry Form
How fast does AMD progress?
  • A good article about how difficult this is to answer
  • Great video that explains why early detection is important especially when detecting the change from dry AMD to wet

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What is Stargardt’s Disease?

Also called Stargardt’s Disease (SD) or Stargardt Macular Dystrophy (SMD) or Juvenile Macular Degeneration (JMD), it’s an inherited, juvenile macular degeneration. The progressive vision loss associated with Stargardt disease is caused by the death of photoreceptor cells in the central portion of the retina called the macula.

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The Science Stuff

Role of RPEs

Geographic Atrophy

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Symptoms

Charles Bonnet Syndrome/Visual hallucinations

Other problems with vision & AMD

  • problems with visual acuity, photostress, blindspots, color vision, sensitivity to light, depth perception
  • eye problems that have similar symptoms as AMD:

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Risk factors

Age

  • Age is a large factor but can start earlier
  • Much less common are several hereditary forms of macular degeneration, which usually affect children or teenagers. Collectively, they are called Juvenile Macular Degeneration. They include Best’s Disease, Stargardt’s Disease, Sorsby’s Disease and some others.  See Stargard’s Disease section above.

Diet/nutrition (working on this section)

  • diet low in various nutrients & high in others have been linked to AMD.
  • See Nutrition and Vitamins/Supplements under Self-care/self-maintenance below.

Race

Gender

  • AMD more common in women perhaps because women live longer than men

Uncontrolled high blood pressure

Uncontrolled high cholesterol

Smoking

Blue Light

Eye Color

Aspirin & other medications

Other possible causes

  • Biological Process in Wet AMD – some evidence that the photoreceptors are starved by the lack of food (oxygen & nutrients in the blood) and the growth of blood vessels is to compensate for that.

Connection between AMD and Alzheimer’s Disease

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Treatments

  • FDA approved options in the US, injections, implantable telescopes, laser treatment (also outside the US)
Injections for Wet AMD
Telescopic implants
Are there new treatments in the pipeline?
Vitamins (see Self Maintenance/Self Care section below)

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Research/Clinical trials

 

How can I become a part of a clinical trial?

  • A list of sources of information about clinical trials and how to find out for you to participate in.
  • You can search for clinical trials from the links above
  • There are registries where you sign up and enter information about the status of your eyes.  Researchers will use this information to find people that match their research and contact you.  Click here for more information about these registries in the US and elsewhere

Gene Therapy

Bionic Eye/Retinal Implants

  • What is a bionic eye?  It’s also called retinal implant or retinal prosthesis.   Implant is put in retina, camera worn by person sends image to implant which stimulates optic nerve
  • Click here for overview of retinal implants including videos of how it works & interviews with people who have them.
  • March 21, 2016 UK Bionic eye being tested
  • Here’s an article about one being developed at Carnegie Mellon institute in Pittsburgh, PA.

Nutritional Supplements

  • See Vitamins/Supplements section below.

Stem Cells

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Coping with low vision

Low Vision Aids

Wearable Technology

  • coming soon!

Suppliers of low vision aids

Financial Help

Sunglasses

Lamps

Transportation

  • A website for the US where you enter your zip code and transportation options for your area will be shown.

Bioptic Driving

Depression

Checking vision

Amsler Grid

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Self maintenance/self care

Low vision rehabilitation

Vitamins/Supplements

Nutrition

Exercise/Activity

 


More to come, you can check out these posts now

Video: Overview of Assistive Technology for People with Low Vision

Highlight: How do I use Zoom for Apple products?

Highlight: What about Apple’s accessibility features?

News: Top 10 Low Vision Aids for AMD

 


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Home

Research

Not being one to be told there’s nothing I can do about something, I went back to my research. There seem to be a couple of different avenues of research. They were working on lasers to blast the drusen, aka piles of eye-poop but it looked to me like a hoarder intervention. Somebody comes in and cleans up the mess one time. Problem solved for now but not later. They would have a clean place to live but would eventually start to become messy again. The second thing I found looked more like the Merry Maids that were cleaning up regularly. However, it did not solve the problem of who is going to feed the Master photoreceptors? The third option was to essentially put the RPE Servants that were left on steroids. The live ones would work harder but would that not mean they wear out more quickly?

There’s research focused on cleaning up the ‘eye-poop’ called drusen.

There was one I liked, OCATA, originally known as Advanced Cell Therapy (ACT) , that was trying to replace RPEs. They were actually giving the little guys some help in order to save the Master photoreceptors. The way they were doing this was with stem cells.

There’s research using stem cells to replace the RPEs.

Although some people see stem cell research as cutting up dead babies, this is not the case. There are several lines of stem cells that have been derived from fertilized eggs that were never implanted. Some of these lines of stem cells are 20 years old. They have been massaged and manipulated so that there would never be the possibility that they could become functioning human beings. If they were not being used for research they would be flushed down the proverbial toilet.

Stem cells can be harvested from old fertilized eggs not dead babies.

The research that interested me–and still interests me–involves stem cells that have been developed specifically to become RPE cells. The theory is that replacing RPE cells with new ones and giving the little Servant guys some help will allow more photoreceptors to live and turn light into sight.

So where, pray tell, does one find someone to do this procedure? The problem is that this is very new research. It has worked on rats and other traditional lab animals (and you college psychology students, I am not speaking of sophomores). However, work on human subjects is just beginning. At the time of this writing, hospitals in Florida, Massachusetts, California and Pennsylvania as well as in foreign locales such as London and China have only completed phase 1 research. Phase 1 of any clinical study is the safety and tolerability portion. [Lin/Linda: it’s 2018 & some of these studies have advanced to the next phase or phases. The links before will give you current information]

Warning: there are doctors and clinics in the US that are offering costly stem cell treatments that have NOT been proven safe or effective through research.  Before you enter into any stem cell treatment, please do your homework!  Click here for an excellent article called Nine Things to Know About Stem Cell Treatments.

Click here for current research using stem cells for Macular Degeneration

Phase 1 results have been extremely promising. For those who are capable of using the web, there is a Lancet article by Schwartz and Regillo that summarizes the study. Essentially, they found the stem cells did not do anything strange or different when implanted in eyes. Preliminary data suggested that it was safe and tolerable. Even more exciting, they found positive therapeutic effects. A great number of the people who had volunteered and participated in the study showed cessation of deterioration and even improvement.

Phase 1 trials using stem cells is VERY promising.

So why not replace the photoreceptors as well as the RPEs? After all, when the RPEs die, the photoreceptors die. Would it not be reasonable to replace them both?

Unfortunately, medical science is not to this point as of yet. They have been successful in growing photoreceptors in the lab. They have been successful in implanting photoreceptors in the eyes of rats. The only problem is that these will not connect into the neural net. It’s sort of like having invented a cell phone without having a tower for it to work through. You can talk on your phone all day but the message goes nowhere.

They can grow photoreceptors in the lab, implanting them in rats but they won’t connect to the neural net.

That said, they are still working on it very diligently. Some of the literature suggests that it will be quite awhile. However, it will be coming.

If you are interested in seeing some of the studies that are being done on eyes and other medical research, I would invite you to go to the clinical trials website. It is a government website that lists all sorts of fascinating things. Many of them are looking for clients.

You will discover that there are dozens, if not more, of studies that are related to eyes. There are multiple studies related to Age-Related Macular Degeneration. So why would that be?

Someone, I am not remembering who at the moment, has launched the Audacious Goal Project. The Audacious Goal Project is aiming to eradicate blindness in the lifetime of some of you younger folks.

Click here to learn more about the Audacious Goal Challenge in Vision Research and Blindness.

Like the name says it is an audacious goal!

Why now?

And questioning again, why now? What is happening that vision is such a hot topic that we need a national program to deal with blindness?

The truth of the matter is, the pig through the population python is getting towards the end. We baby boomers from the 50s and the 60s have always presented challenges. We have always been very popular and our hot topics have been the topics of the nation. When I was a little girl, they were building elementary schools left and right. Then everything was sweet 16 and on through my lifespan. Right now, everything is security call buttons and retirement accounts. We drive the economy.

We baby boomers from the 50s and 60s have always presented challenges.

Because there are so many of us, our concerns are essential. One of our big concerns is vision. According to my research, AMD is the leading cause of blindness in the developed world. In the United States alone there are as many as 11 million people who have some form of AMD.  They are predicting there will be 22 million by 2050! 

This is going to be a massive drain on the country. When somebody suddenly realized what the numbers were going to look like, they decided they had better do something to ameliorate the problem. Thus, all the research.

Click here for more facts & figures from 2016

As many as 11 million people in the United States have some form of age-related macular degeneration. This number is expected to double to nearly 22 million by 2050.

Written in February 2016. Reviewed September 2018.

Continue reading “Research”