Have Wet AMD and Hoping for Something Other Than Injections?
I am starting my fourth year working with those who have macular degeneration. In my Facebook group, one of the most common topics, when I started it in 2016, was the injections in the eye for wet AMD or choroidal neovascularization (CNV) in other types of macular degeneration. Four years later it still is.
Eye injection anxiety
No one relishes the idea of having a needle put into their eye! In my article Anxious About Those Eye Injections?, I talk about ‘eye injection anxiety’ which occurs in some people who are receiving this treatment, especially when they are just beginning.
Living Well With Low Vision
One of the best sources of information about the current state of research is the non-profit organization The National Society to Prevent Blindness and their site Living Well With Low Vision. This site was created by and continues to be the project of Dan Roberts who has a visual impairment from AMD. He’s an author and advocate for VIPs (Visually Impaired Persons).1
Every year Dan publishes a 'Summary of Research and Developments.' If you are interested, I recommend that you check out the summary article for 2019. One thing we can count on from Dan is that he keeps his information up-to-date.2
What macular degeneration research is happening?
There are several approaches being researched (you may hear this referred to as research in 'the pipeline’):
I won’t list the details about each of these clinical trials. I admit I have a hard time keeping up with the latest developments with their strangely-coded names. That is actually good news because that means that there is a LOT in the research pipeline!
Clinical trial phases
Research follows specific guidelines and is part of a process of phases that build on each other. Here's a quick review of them (there's more in the article Clinical Trials Basics):
- Phase 1 or I: A small number of people are administered a treatment which is studied for its safety.
- Phase 2 or II: A larger number of people participate and are administered a treatment which is studied of its effectiveness. Often, phase 1 and 2 (phase 1/2) are combined so that both safety and effectiveness are studied in one clinical trial.
- Phase 3 or III: A large number of people participate and are given the treatment. Safety is always a concern as is effectiveness and any side effects are investigated. This stage determines if the treatment is ready to be released to doctors for the public.
- Phase 4 or IV: This is where the FDA gets involved and any final adjustments are made. FDA approval is required if the treatment is to be ready for the public.
Recent advancements in anti-VEGF
The big news in 2019 was that a new anti-VEGF medication Beovu (brolucizumab) was approved by the FDA. Beovu was shown in clinical trials to extend the time between injections to 12 weeks. In addition, it was also shown to improve visual acuity, something that doesn’t always happen with its predecessors. Retinal specialists have started to use Beovu. Some of the members of my Facebook group have been started on it. We are all very hopeful!
Anti-VEGF medication research
There are at least 4 clinical trials working on new anti-VEGF medications that will allow more time between injections, either by themselves (called monotherapy) or in addition to Lucentis (called combination therapy). You’ll hear about these medications: Abicipar, OPT-302, RG7716, faricimab, and REGN 910-3, GB-102 and KSI-301.2
Port delivery system
There is also a phase 3 clinical trial underway using a tiny device (the size of a grain of rice) with Lucentis (ranibizumab) in it that is implanted in the sclera (white outer layer) of the eye under local anesthesia. The Lucentis is released slowly and the device called a 'port' is refillable. The system is called the Port Delivery System or PDS. The phase 2 research showed it to be safe to insert and refill. Currently, phase 3 is hoping to confirm the safety and further define the benefit of the PDS.3
Replacing eye injections
I’ll bet you are more interested in treatments that don’t require any injections, right?
Probably the number 1 hope is that there will be a treatment for wet AMD that a person with it can administer themselves. The problem has been that so far, eye drops are unable to deliver medication to the retina in the back of the eye.
There are two research projects using eye drops which is also called ‘topical treatment.’ Both have completed phase 1/2 or phase 2 clinical trials and have proven to be safe. They also made sure the medication was reaching the retina. The next phase will investigate their effectiveness in controlling wet AMD/CNV.2
Also, as I am writing this, one of the big stories of the week is that a company called Exonate announced they'll be working with Janssen Pharmaceuticals, Inc. (of Johnson & Johnson) to develop eye drops for AMD.4
There are 2 oral medications (AKST4290 and X-82) that completed phase 2 clinical trials. One has been tested on those whose wet AMD is newly diagnosed and before any anti-VEGF injections. The second one is being used with Lucentis to reduce the number of injections needed. Both have been shown to be safe and research will move to the next phase.2
One of the very promising and exciting topics of research is that of gene therapy. The simplest explanation of what that could mean is that a person with wet or dry AMD could have a one-time procedure where a faulty gene causing the disease or its progression could be fixed and the disease would be stopped! I've written more about it in my article Gene Therapy Research for AMD so I won't go into detail here.
There are 4 clinical trials in the early stage (phase 1/2) where safety has been explored. With 2 of them (RGX-314 and ADM-022), early results show both safety and effectiveness in reducing the need for anti-VEGF injections.2
Restoring lost vision
Stem cell therapy
What happens if wet AMD has caused the death of the photoreceptors that give us sight? That's what stem cell research is working on. It's a subject for its own article! You can get a preview of what this is in the article: What Are Investigational Therapies?
Did I miss any?
If you find that I've missed significant research that you know about, please let me know. As I said, it really is hard to keep up with it!
I wish I could tell you (the crystal ball I ordered never got delivered 😀). As I wrote above, each clinical trial must go through a detailed process before it gets to your retinal specialist. How long that takes is very specific to the clinical trial. I'll keep you posted!
I hope that you are as optimistic as I am about the future. If you want to read more about research that is working on a CURE, you might read my article 2020: Not Only a Date – A Deadline! A Cure for AMD in Our Lifetime? For those of you with dry AMD, I have an article for you about research into dry AMD (coming soon!) Have Dry AMD and Wonder When There Will Be a Treatment?
Do you feel that you've maintained independence with macular degeneration?