Where Is My Dry Macular Degeneration Clinical Trial At Now?
I have been called back to the clinical trial. I went for an abbreviated examination and my shot yesterday.
Things are looking good so far
I was a bit surprised to be called back so soon. In real-time (mid-May) we are still in the midst of the COVID-19 mess. However, the precautions were good. Also, I heard the preliminary findings are looking good. Forgive my cynical nature, but when you are in a race to bring to market the first treatment for dry AMD, time is money. BIG money.
Delayed clinical trial results due to COVID-19
This is a 36-month study. It will be another two years before there are final results. Before COVID-19, we were told we would be briefed about the progress this spring. Not sure if and when that will be happening now. However, given the fact I was told things are looking really good, I decided to go on the internet and see if I could find out exactly how good.
My dry macular degeneration clinical trial
If you knew and forgot or if you did not know, I am in a clinical trial for APL2. The study is testing whether or not the drug APL2 - aka pegcetacoplan - slows the growth of lesions on the retinas of people with geographic atrophy. That is dry age-related macular degeneration. The drug company is Apellis who is in association with Wills Eye Hospital who is in association with MidAtlantic Retina.
What is APL2 for dry macular degeneration?
APL2 is administered by intravitreal injection. That means someone literally pokes a needle in my eye...and no, so far it does not hurt at all. The medication is a complement factotum inhibitor targeting C3. Basically, in order for your immune system to attack your retina - age-related macular degeneration being an autoimmune condition - a whole bunch of chemical reactions have to happen in a certain order. Like a line of dominos. APL2 takes out the domino called C3 and stops some of the subsequent dominos from tumbling.
That is a quick and dirty review of the background science. What did I find about efficacy?
Finding results from a phase 1 study
The article I found was basically a press release by Apellis. The date was April 28 of this year (2020) and the title was Apellis Reports Analysis from Phase 1b Geographic Atrophy Study. The phase 1b study was safety and tolerability and only had 12 people. However, the formulation of the drug was reported to be the same as the one now being used in the phase 3 study I am in. That means some parallels can be drawn and maybe even predictions made.
So, what were the results?
The bottom line for our purposes is this: the growth rate of the lesions in the study eyes was reduced by 31% as compared to the growth rate of the lesions in the other, non-treatment eyes. Basically, that means I could be going blind at 69 miles per hour instead of 100. This reduction in growth rate is consistent with what they found in their phase 2 study.
So, results are consistent and therefore reliable. This is a good thing. The article says another thing that is generally consistent is the degeneration of both eyes when those eyes have GA. Seeing a 31% reduction in the treated eyes means something.
Looking forward to dry macular degeneration treatments
I don’t know and nobody hinted at anything but I would suspect they might be looking at similar slowdowns in the study I am in. If they are, that would be great.
I am proud to be a small part of medical history and I am glad the study is back. If you have the opportunity to contribute to finding a treatment and eventually a cure by being in a clinical trial, please do. Together, we can beat this.
Have you visited our new sister site, ChronicDryEye.net?