Pegcetacoplan Side Effect Hunting
For the past year and a half, I have been in a new study. The title is... wait for it... A Phase 3, Open-Label. Multi Centered Extension Study to Evaluate the Long-Term Safety and Efficacy of Pegcetacoplan in Subjects with Geographic Atrophy Secondary to Age-Related Macular Degeneration...1
Phew! Who comes up with these titles, anyway? In any case, the primary outcome measure is to determine the incidence and severity of ocular and systemic adverse effects. Translation? We are side-effect hunting.
Why would a seemingly intelligent, seemingly sensible, nearly 70-year-old set out to find side effects? I could give you the answer that would suggest I am a self-sacrificing soul: if not me, who? If not now, when? A small part of that is true, but not much.
I could give you the answer that has me being seen as much more self-serving: being included in this study and trying to ingratiate myself will give me traction for getting into the study they hopefully will do to see how well long-term APL-2 eyes do with stem cell therapy. That answer has more validity.
However, probably closest to the truth is this: I am a born optimist and a trusting soul. I just don’t see a lot of chance my, personal, side-effect hunt is going to lead to any adverse events.
And why would that be? Naive? Probably? Maybe? There are people who are diametrically opposed to the thought of APL-2 (Pegcetacoplan is too hard to spell!). APL-2 frightens some people with GA. They see the adverse event of conversion to wet age-related macular degeneration (AMD) to be a deal-breaker. ‘Not me! I am not taking the chance!” They scream.
Not trying to convince anyone here. I am not a retina specialist and believe everyone should make up their own mind with input from a doctor. Just want to present my own thinking. Take it or leave it.
In my case, I believe both my father and his father had dry age-related macular degeneration. My father was just shy of 87 when he passed. Neither he or my grandfather converted to wet. I would say heredity is on my side there.
I have also been told by a retina specialist he would be surprised if I ever converted naturally. My impression was my macula did not have enough left to convert. And even if that were not the case, general consensus is only 10 to 15% of AMD folks become “wet” anyway. The rest either do not progress to advanced disease or they develop geographic atrophy. Like me.
All that by way of saying, I don’t believe a conversion to wet would normally be in the cards for me. What about under circumstances that are not quite “normal”? What about when under APL-2 treatment?
What the studies say
In writing for the International Journal of Ophthalmology, Rubner et al reviewed the adverse effects found after the FILLY, phase 2 trial. The article reported there was an overall conversion from dry to wet of 20.9% in the monthly injection group and a rate of 8.9% in the every other north group.2
That sounds pretty bad until you read a bit further. It was reported that subjects with wet AMD in the non-treated eye converted at a rate of 36.9% when treated monthly and at the rate of 17.9% when treated every other month.2
If the subjects had no history of wet AMD, monthly treatments had them converting at a rate of 10%. The conversion rate was 3.9% in those with every other month treatments. 10% conversion rate mean 90% chance it won’t happen. Would I take those odds? I am doing just that right now.2
Looking for more
Google Scholar and I looked for the rates for the phase 3 trials. The results are either not out or the journal would want me to pay for the article. I don’t pay for articles. Therefore I don’t know how adverse events went for phase 3. I will keep looking.
Bottom line on all of this seems to me to be this: if you have a tendency towards wet AMD, APL-2 could give you a 3 in 10 chance of converting before your time. Good chance you will convert, but not as fast. If you are not inclined towards converting, your chances of converting now appear to be about 1 in 10. Either way, check with your doctor.2
That’s it for me. Susie the Side-Effect Hunter signing off.
Have you gotten a second opinion about your macular degeneration?
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