Sean Adrean, MD, of Retina Consultants of Orange County, discusses his study presented at the 2024 AAO Annual Meeting, titled “Aflibercept 8mg for DME: Week 96 Efficacy Outcomes by Baseline Characteristics in the PHOTON Trial.”
Sean Adrean, MD:
We’re going to present information on the PHOTON phase 3 DME trial, and I’m presenting on behalf of all the PHOTON investigators. This is a phase 3 trial and it’s split patients into a 1:2:1 grouping. There was the 2 mg treatment group that was every 8 weeks; there was an 8 mg group that was every 16 weeks, and another 8 mg group that was every 12 weeks. The group that was 12 weeks had twice the number of patients as either the 2 mg 8 weeks and the 8 mg 16 weeks.
As far as the study design went, they went ahead and looked at patients with diabetic macular edema that was central involved, and they could have a visual range between 20/32 to 23/20. Patients were enrolled even if they were previously treated. A good 44% of patients had had previous treatment for diabetic macular edema and they were still able to be enrolled in this trial.
The purpose of the trial, the top-line outcome, was to look at best corrected vision at week 48, and those results have already been published, and then also out to 96 weeks, which was the end of the trial, and of course the primary endpoint was the best corrected vision. This study is looking at the subset data based on both race, ethnicity, as well as baseline demographic characteristics of the patients, including things like their central subretinal thickness and best corrected vision at entry into the study and looking at that different data to see how patients did overall with treatment at the 2-year time point. We’ve previously reported the 1-year time point, and we wanted to see how patients did. In the second year, patients were able to be extended even further out to 20 weeks or to a maximum of 24 weeks in this study and wanted to look and see how these patients did.
When we look at these different study findings, the main conclusion is that in any of these different groups, if we look at both their patient’s age at entry, at patient’s baseline demographics, if they’re male or female, their ethnicity or their race, and when we look at all of those different data, all of these patients had non-inferior gains in between the different subgroups, and they all performed equally as well within these different subgroups. The main takeaway message is that any of these patients that are treated with the extended dosing interval at the 8 mg, we’re able to maintain these very good visual outcomes when compared to 2 mg of aflibercept out at 96 weeks with the extended dosing, so that’s great because there would be fewer injections given for these patients over the 2-year time period that the patients were in the trial.
Patients have a high injection burden with these different disease states, and so especially for the diabetic macular edema patients that tend to be a younger population, sometimes coming into clinics and getting these injections where the treatment burden is high, getting an injection every other month or every month in some cases, if we could extend out those time intervals so these patients require fewer injections, that’s both more helpful to get these patients back in with their jobs and everything like that, as well as fewer side effects that you could potentially see with a higher injection burden.
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