The phase 2 trial results were very positive in regards to its safety endpoints and the efficacy endpoints were very encouraging.
The use of intravitreal aflibercept injections (IAI) met primary endpoints for the prevention of macular edema post-cataract surgery in those suffering diabetic retinopathy, according to Rishi Singh, MD, of the Cole Eye Institute at the Cleveland Clinic (pictured).
The injection did not show a significant number of adverse events, nor were there meaningful differences in the average gains in visual acuity or central subfield thickness (CST).
Results of the phase 2 prospective single, masked, randomized trial, titled Prevention of Macular Edema in Patient with Diabetic Retinopathy undergoing Cataract Surgery with Intravitreal Aflibercept Injection (PROMISE), were presented at the American Society of Retina Specialists annual meeting in Boston.
“The study basically found a significant number of patients developed macular edema following surgery,” Singh told MD Magazine. “In the sham arm, about 50% of patients developed macular edema, if you lose a couple different criteria definitions for that, and for those patients in the aflibercept arm, the rates were much, much lower, in the 10% to 14% range.”
Patients were randomized 1:1 to 2 study arms: One receiving IAI, and the other a placebo injection, at the time of cataract surgery. Both groups were examined at day 7, 30, 60, and 90 following the surgery.
At day 30, 16.7% of patients receiving aflibercept gained less than or equal to 15 letters, compared to 30% in the sham arm. At day 60, the sham arm saw that percentage decrease to 22.2%, while the aflibercept arm increased to 45.5%. By day 90, 30.8% of aflibercept patients gained less than or equal to 15 letters, compared to 44.4% of the placebo group.
69.2% of patients in the aflibercept arm were 20/40 or better at baseline compared to 46.2% in the sham group, and following days 30, 60, and 90, the aflibercept arm increased to 91.7%, 90.9%, and 92.3%, respectively. Likewise, the sham arm had 100% of patients 20/40 or better at day 30, then 89.9% and 100% at days 60 and 90, respectively.
While aflibercept did not show significant differences for the duration of the 90-day trial, at day 90, 38.5% of those receiving aflibercept were 20/20 or better compared to only 11.1% in the placebo group.
“We did see anatomical benefits, and probably the one that I think is the most important benefit of this study was those patients were 20/20 following surgery,” Singh told MD Magazine. “In those groups, a significantly higher percentage of patients in the aflibercept arm were 20/20 or better following surgery versus those in the sham-treated groups.”
“Those patients achieving 20/20 or better visual acuity are probably more likely with the drug than without based on what we’ve seen from the phase 2 study,” he added.
Singh, R. (2017). Prevention of Macular Edema in Patient with Diabetic Retinopathy undergoing Cataract Surgery with Intravitreal Aflibercept Injection (PROMISE). Presented at: 35th Annual Meeting of the American Society of Retina Specialists; August 11-15, 2017; Boston, Massachusetts.