The trial examined 2 doses of aflibercept versus sham in patients with good visual acuity and no center-involving diabetic macular edema.
The ongoing PANORAMA trial randomized patients with non-proliferative diabetic retinopathy (NPDR) to sham or either of 2 aflibercept injection frequencies. Both treatment arms met the primary endpoint of the proportion of patients achieving 2 or more step DRSS improvements, compared to sham.
Charles Wykoff, MD, PhD, Retina Consultants of Houston, and Deputy Chair of Ophthalmology at Blanton Eye Institute, Houston Methodist Hospital spoke with MD Magazine® about the study details at the 2019 Annual Meeting of the Association for Research in Vision and Ophthalmology (ARVO) in Vancouver, BC.
Wykoff shared about the trial design and he emphasized that the participants had well-sighted eyes with a visual acuity of 20/40 or better, and at baseline, an average visual acuity of 20/25.
In the first part of the interview, Wykoff shared about the context of the PANORAMA trial.
So, PANORAMA itself is a global, phase 3 program. It's a multicenter, randomized trial in which 402 patients were randomized equally to 1 of 3 arms. The first arm was sham injections and then there were 2 dosing frequencies of aflibercept. And the aflibercept dosing frequencies were every 16 weeks or every 8 weeks, after 4 and 5 loading doses, respectively, and then the primary end points were at both months 6 and a month 12. The primary end point was the proportion of patients with 2 or more step DRSS improvements. So, it's basically a color fundus photograph primary end point, looking at improvement in retinopathy severity scales. A key secondary end point was to look at the development of vision-threatening complications, so proliferative disease, center-involved DME.Enrolled patients were anti-VEGF treatment-naive, with good vision—they had to have 20/40 or better visual acuity—with no center-involved DME. And speaking to that, at baseline, the average visual acuity was 20/25. Just again to emphasize, these are well-sighted eyes and their center retinal thickness of baseline average was less than 250 microns. So, there's no DME in these eyes and they're well-sighted, very unique population from what most of the anti-VEGF trials have looked at, which are mostly DME patients. And at baseline, just to round out the demographics there, the A1C was about 8.5 and then there was about a 14-year history of diabetes. So, obviously these are all diabetic eyes with NPDR without DME.