Take-home: Patients with diabetic retinopathy have a high risk of developing macular edema after cataract surgery. Intravitreal injections of aflibercept might result in fewer patients developing macular edema in this patient population.
The PROMISE study, which evaluated the efficacy of injections of aflibercept (Eylea, Regeneron Pharmaceuticals) to prevent macular edema after cataract surgery performed in patients with diabetic retinopathy, found that macular edema developed in fewer patients in this population compared with sham-treated patients without adverse events.
The report on a partial portion of the cohort found no meaningful differences were seen in the gains of visual acuity, but there were statistical differences in the central subfield thickness (CST) at days 7, 30, and 60 between the 2 groups.
Finding a treatment to prevent macular edema is an important goal in that its development can affect the visual outcomes after cataract surgery. It also impacts the spectrum of patients–ranging from healthy patients who undergo an uneventful cataract surgery to those who experience complications, such as a posterior capsular rupture or iris trauma, to patients with diabetes who already have retinopathies and are particularly susceptible to development of the disorder after cataract surgery, according to Rishi Singh, MD.
Dr. Singh is a staff surgeon at the Cole Eye Institute, an associate professor of ophthalmology, Lerner College of Medicine, Cleveland Clinic, Cleveland.
This prospective randomized phase II trial included patients undergoing cataract surgery who had a history of nonproliferative or inactive diabetic retinopathy and no clinically significant macular edema. Patients were randomized to either intravitreal aflibercept or sham injections at surgery.
The primary study objective was to determine the incidence and severity of ocular and non-ocular adverse events over the course of the 90 days of the study. The secondary objectives were the percentage of patients in whom macular edema developed within that time frame after cataract surgery.
The definitions used were a 30% or greater increase from the preoperative baseline in the CST, a decrease in the best-corrected visual acuity (BCVA) exceeding 5 ETDRS letters from day 7, and loss of visual acuity resulting from retinal thickening. Another study endpoint was the presence of cystoid abnormalities detected on optical coherence tomography (OCT) images at any visit, Dr. Singh recounted.
The targeted enrollment was 30 patients. Dr. Singh presented data for 26 patients who completed the 90-day evaluation.