Transcript
Announcer:
You’re listening to Eye on Ocular Health on ReachMD. On this episode, we’ll hear from Dr. Michael Klufas, who’s Member of the Retina Service at Wills Eye Hospital and is an Associate Professor of Ophthalmology at Sidney Kimmel Medical College of Thomas Jefferson University. He’ll be discussing his recent analysis, which explored real-world use of aflibercept eight milligram in eyes with diabetic macular edema. Dr. Klufas presented this analysis at the 2026 American Society of Retina Specialists Annual Meeting. Let’s dive in now.
Dr. Klufas:
This analysis from the American Academy of Ophthalmology Iris Registry, the ILLUMIN-8 study, was done to look at the real-world use of aflibercept eight milligram in eyes with diabetic macular edema. Having this large registry study allows us to see how aflibercept eight milligrams performs in real-world use outside of the clinical trial setting.
We wanted to look at treatment-naive eyes that initiated aflibercept eight milligrams, and also eyes that were previously treated with aflibercept two milligrams and switched to aflibercept eight milligrams. So, when we looked at the registry, we actually found that there were nearly 40,000 diabetic macular edema eyes. But we also wanted to follow these eyes for at least six to 12 months after the switch. So basically, when looking at these 40,000 eyes, we were able to whittle it down to about 450 treatment-naive eyes, and about 2,700 or so eyes switched from two milligrams. And we were looking at the last injection interval and change in visual acuity.
Looking at the demographics, clinical characteristics, and follow-ups of both treatment-naive and switchers, in terms of age, the mean age was about late 60s in both cohorts, and about 50, 55 percent were male. In terms of race and ethnicity, about 65 percent were Caucasian or White in both cohorts, about 10 to 11 percent were African American/Black, and about seven percent or so were Hispanic or Latino.
So what did we actually find with regard to treatment interval? In the treatment-naive diabetic macular edema patients, we observed that the average or median treatment interval was about 12 weeks in the treatment-naive cohort, which is very consistent with the registry clinical trial data. And then in terms of the change in visual acuity from the index date to the last injection, there was no change in this treatment-naive cohort. However, if we’re looking at the visual acuity change from the index date with eyes that had vision 20/50 or worse, there was about a nine-letter gain.
Also, when we moved to the switcher cohort from aflibercept two milligram to eight milligrams, we found that the median duration from the last treatment was also 12 weeks and represented an extension of about two weeks from the last pre-switch interval. And there were also some patients who were able to go longer in this cohort. If we looked at the breakdown of these 2,700 eyes, there were about 1,100 that were six to eight weeks, 600 that were eight to 10 weeks, 423 that were 10 to 12 weeks, and 400 that were 12 to 16 weeks. And in these switched eyes that had previously been treated, there was no change in visual acuity from the index date to the last recorded aflibercept eight milligram injection.
Limitations: the study was obtained from electronic medical records, so it might not capture every patient's complete medical history, and best-corrected visual acuity data may not be consistently available.
And then in these treatment-naive and previously treated eyes, overall, the median injection interval was about 12 weeks, and visual acuity was maintained. And it's important to remember that these treatment-naive eyes with low baseline visual acuity—less than 65 ETDRS letters—showed the greatest visual improvement of about two lines of ETDRS vision, or nine letters.
This study gives us greater confidence that we're seeing data that's replicated from the clinical trial in the real world. With many of these second-generation anti-VEGFs, are we able, in the real world, to apply that same retreatment criteria, or do we allow less or more fluid?
But my takeaway from the major registry trials with aflibercept eight milligrams, both in diabetic macular edema and neovascular AMD, is that many patients are able to achieve a 12-week or longer treatment interval. And we're seeing that the median treatment interval is about 12 weeks in this real-world study as well. And I think it's also nice to see in our diabetic macular edema patients—especially those that start at vision 20/50 or less—that there's about two lines of vision gain, which is consistent with many other diabetic macular edema trials, as well, over time.
Announcer:
That was Dr. Michael Klufas walking through his recent analysis, ILLUMIN-8. To access this and other episodes in our series, visit Eye on Ocular Health on ReachMD.com, where you can Be Part of the Knowledge. Thanks for listening.
