For patients with nonproliferative diabetic retinopathy (NPDR) without center-involved diabetic macular edema (CI-DME), treating early with aflibercept may slow disease progression, but it does not appear to positively impact vision.
Study design
This is a 4-year prospective, randomized, multicenter clinical trial of 328 adults (399 eyes) with moderate-to-severe NPDR but without CI-DME. Eyes were randomized to intravitreal aflibercept or sham groups (200 vs 199 eyes, respectively) in which participants received 8 injections over the first 2 years followed by quarterly injections for another 2 years unless the eye improved to mild NPDR or better.
Outcomes
The 4-year probability of developing proliferative diabetic retinopathy or CI-DME with vision loss was 34% with aflibercept, which was significantly lower than the 57% probability seen with sham participants. No significant difference in visual acuity change was noted between the two groups.
Limitations
There was only a 75% retention rate among participants.
Clinical significance
Despite a significant reduction in disease progression, early administration of anti-VEGF for NPDR without CI-DME does not appear to produce any long-term visual benefits. Close follow-up of patients is important to treat vision-threatening complications of diabetic retinopathy. The 34% rate of developing proliferative diabetic retinopathy or CI-DME among patients in the aflibercept group highlights the importance of non–VEGF-mediated aspects of diabetic retinopathy progression.
Financial disclosures: Dr. Ajay Kuriyan discloses financial relationships with Adverum, Annexon, National Eye Institute (Grant Support); Alimera Sciences, Allergan, Bausch + Lomb, EyePoint Pharmaceuticals, Novartis, Alcon Pharmaceuticals (Consultant/Advisor); Genentech (Consultant/Advisor, Grant Support); Lumata Health (Consultant/Advisor, Private Equity/Stock Holder); Optos, Spark Therapeutics (Lecture Fees/Speakers Bureau); Recens Medical (Consultant/Advisor, Private Equity/Stock Holder).