Advances in the Clinical Management of Diabetic Macular Edema and Age-Related Macular Degeneration - Episode 10
Thought leaders review the clinical and practical implications of a novel port delivery system for the treatment of neovascular age-related macular degeneration [AMD].
Carl D. Regillo, MD, FACS: It’s quite a different treatment paradigm. Can you tell us about port delivery system [PDS], as it is referred to?
Blake Anthony Cooper, MD, MPH: You’re right. It’s an exciting time because we have now a different vehicle or way we can deliver anti-VEGF therapy. This is an innovative drug delivery system, so it’s actually an implantable device that can be refilled at variable intervals. What happens is that patients are taken to the operating room, an incision is made in an area on the eye called pars plana, which is an area that we oftentimes put various incisions in to be able to gain access to the vitreous cavity. That implant that stays inside the eye will continuously release ranibizumab to inhibit VEGF for 6 months at a time, so patients aren’t coming back every month for an injection. It can be refilled though in the office, similar to the way we would do an intravitreal injection. It’s always exciting for those who are risk adverse effects to intravitreal injection, as they have another option for them. When you start to consider whether or not this is a good treatment option, you have to, again, have that individualized patient approach. From my standpoint, I feel like it’s going to work best in those who already had cataract surgery. Those who have good conjunctiva so that we can make sure that implant is well covered. You have to pick the people who understand that you’re trying to reduce their treatment burden. It should be noted that there is a higher risk of endophthalmitis or an infection that can occur in the eye. Patient selection is extremely important. I look back over the course of my career, the way we removed cataracts, and how phacoemulsification evolved. It went from a scleral tunnel incision to a clear corneal incision, and at that time we oftentimes saw a higher increased rate of endophthalmitis with clear corneal incision that we don’t see as often anymore. I think oftentimes, our techniques are going to continue to hopefully improve to reduce that risk for infection. It should also be noted that there are two ongoing trials PAVILION [NCT04503551] and PAGODA [NCT04108156] for those who live with diabetes looking at different types of diabetic retinopathy. For those who have diabetic macular edema as well as those who have levels of retinopathy, as we mentioned earlier anti-VEGF suppression can reverse the stages of retinopathy.
Carl D. Regillo, MD, FACS: This is truly a different treatment paradigm. It is sustained delivery, it’s not bolus, often spaced intravitreal injections. As you said, it’s a reservoir-like device that is implanted surgically and refilled in the office. It predictably and reliably gives us about 6 months of solid anti-VEGF effect. Very few patients need supplemental injections and that’s what the phase 3 Archway study [NCT03677934]showed––over 95% of patients did not need anything else other than getting the device refilled every 6 months. We know it could even last longer. What type of patients would you consider this treatment for?
Blake Anthony Cooper, MD, MPH: Again, it would probably be those who are risk adverse effects to intravitreal injections. Those who oftentimes have a large health burden and would have a hard time coming back and forth on a regular basis or rely on individuals to bring them into the office. For now, I’m really looking at those who already had cataract surgery and have good conjunctiva just to hopefully help reduce that risk for potential infection.
Transcript Edited for Clarity