麻豆果冻传媒影音

Findings from a post hoc analysis of the and studies were presented at the recent American Academy of Ophthalmology (AAO) meeting, showing that use of AREDS supplements may reduce the progression of geographic atrophy (GA) toward the fovea, though not the overall size of GA lesions.

MedPage Today brought together three expert leaders in the field: Moderator Peter K. Kaiser, MD, of the Cleveland Clinic, is joined by Yasha S. Modi, MD, of New York University Langone Health in New York City, and Arshad M. Khanani, MD, of the University of Nevada in Reno, for a virtual roundtable discussion. This last of four exclusive episodes focuses on the implications of these findings for GA treatment and clinical trials.

Click here to watch the other videos from this AAO roundtable series.

Following is a transcript of their remarks:

Kaiser: So the other thing that came out of AAO, which I thought was fascinating, was evaluation of an old study, the AREDS and AREDS2 study. Historically we're always taught that the vitamins and the vitamin supplementation really doesn't affect geographic atrophy. And so we never really thought about it. But recent data from both those studies were presented at AAO, and Yasha, why don't you tell us about some of these studies and why this may change our thinking?

Modi: Yeah, actually, I feel like I learned that piece of information from you about the fact that it only works on exudative macular degeneration because that's what the evidence showed. And it was a really interesting study by the National Eye Institute.

What they did was they went back and looked at two cohorts. They looked at the AREDS original cohort and the AREDS2 cohort, and the way that they broke it down was different than what we normally consider. They talked about proximity-based progression, basically the geographic atrophy moving closer to the fovea. And then they talked about area-based progression, basically the enlargement of the geographic atrophy.

Ultimately, what we care about is sort of proximity-based geographic atrophy. How close is it moving towards the fovea? And interestingly, both AREDS and AREDS2 vitamins relative to sham showed a reduction in the progression towards the fovea, but, interestingly not in terms of the overall geographic atrophy size.

So the conclusion is that probably we should be leaving patients on their AREDS vitamins, their AREDS2 vitamins. Now remember, this is a post hoc analysis, so it's going to have to be tested in a randomized fashion. And it also begs the question, when we're thinking about future GA studies, is it reasonable to consider sham? Is it something that they should be on AREDS2 vitamins? Should pegcetacoplan [Syfovre] or avacincaptad pegol [Izervay] be the appropriate control? So would love to get your thoughts on that.

Kaiser: Well, I'd love to hear Arshad's thoughts. He helps design many of these dry AMD [age-related macular degeneration] studies. What do you think about this data? Does it make you think of things you need to do in the patients in these GA studies?

Khanani: Oh, definitely. I think this is very important work. In the past, we didn't pay attention to the fact that whether they're on AREDS2 or not in terms of inclusion and exclusion. And so this is very meaningful because if you have more patients taking AREDS2 in your treated arm, you may have a different efficacy profile in terms of growth towards the fovea, and similarly, if you have more patients in the control arm taking it.

It's a very important point, because we have seen different efficacy rates in GATHER1, GATHER2, and DERBY and OAKS. They were balanced, well balanced for GA lesion size, and all the other stuff. But one thing that I've not seen presented is patients who are on AREDS2 and what was the proportion in the treated or control arm?

So I think this is a huge impact. And we have many trials that are looking at oral formulations of drugs, systemic treatments for GA, and here it becomes even more meaningful whether patients are on AREDS2 or not. So I think this is really important data. Thanks for sharing it, Yasha.

Kaiser: I couldn't agree more. We knew that it helps prevent progression late, mainly in CNV [choroidal neovascularization], but this also says that a patient with GA should also be on these medications. And again, for the clinical studies, it's obvious you almost have to make sure that everybody in the study is on the vitamin, both groups basically, to prevent any bias in your treatment groups.

So, really, this was a great discussion about some of the really important findings from AAO. I want to thank you guys for joining me today on this AAO roundtable.

Modi: Thank you, Peter.

Khanani: Thanks so much for having us.

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