Aflibercept not only significantly improved patients’ DRSS scores, but it also reduced vision-threatening complications by 75% compared to placebo.
The PANORAMA study in patients with non-proliferative diabetic retinopathy (NPDR) found that aflibercept injections every 16 weeks (Q16) and every 8 weeks (Q8) resulted in 65% and 80% of the patients improving 2 or more steps on the diabetic retinopathy severity scale (DRSS) compared to 15% of those in the placebo group.
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’s 52-week primary endpoints at the 2019 Annual Meeting of the Association for Research in Vision and Ophthalmology (ARVO) in Vancouver, BC. Wykoff also highlighted the secondary endpoints of proliferative disease or center-involved DME as important pieces of data that will inform management decisions and discussions with patients.
“At some level does it really matter what the color fundus photograph looks like? Does it really matter how many hemorrhages a patient has?” said Wykoff. “It's really a debatable question, but certainly I think what we all care about are the vision-threatening complications: proliferative disease and DME.”
So, through 1 year, the Q16 and Q8 arms received about 5 and a half and 8 and a half injections, compared to—obviously—none in the sham arm, and then at the 1-year time point about 65% and 80% of the Q16 and Q8 arms improved 2 or more steps on the DRSS compared to 15% with sham. So, highly statistically significant differences favoring the aflibercept arms, meeting the 1-year primary endpoint—actually both arms were their own primary endpoint compared to sham, so 2 primary endpoints at the week 52 mark.No, I love it, and just to get in the secondary endpoints briefly, because that will answer the question. It's interesting—doctors and patients—at some level does it really matter what the color fundus photograph looks like? Does it really matter how many hemorrhages a patient has? It's really a debatable question, but certainly I think what we all care about are the vision-threatening complications: proliferative disease and DME and there was a highly significant difference between the arms. About 41% of the sham eyes developed proliferative disease or center-involved DME compared to 8% to 11%—about 10% of the aflibercept dosed patients, so a 75% reduction in the development of these vision threatening complications with treatment.
So, clearly through 1 year of PANORAMA we saw highly effective treatment with anti-VEGF aflibercept dosing, both in improvements retinopathy severity scales, but most clinically relevant, reductions in the development of these clinically relevant endpoints. So, to answer your question directly, I think the most valuable thing that this trial does is it gives us data to inform our discussions or management decisions with patients. Does this trial mean that every patient with NPDR without DME should be treated with anti-VEGF injections? I think the answer to that has to be individualized. Every eye needs to be considered separately in the context of the complete patient, but it gives us data that if you do treat these patients you significantly improve their anatomic outcome, at least through 1-year and ultimately this is a 2-year trial, so we'll have more data forthcoming.