While aflibercept produced significant anatomic improvements in a sham-controlled trial of eyes with nonproliferative diabetic retinopathy (NPDR) without center-involved diabetic macular edema (CI-DME), visual acuity was not improved at 4 years. “Aflibercept as a preventive strategy, as used in this trial, may not be generally warranted for patients with NPDR without CI-DME,” the investigators conclude.
The trial was conducted at 64 clinical sites in the U.S. and Canada in 2016–18. Participants were 328 adults (399 eyes) with moderate-to-severe NPDR (Early Treatment Diabetic Retinopathy Study [ETDRS] severity level 43-53; range, 0 [worst] to 100 [best]) without CI-DME. Aflibercept 2.0 mg or sham was injected intravitreously 8 times at defined intervals over a 2-year period, with continuing quarterly injections through 4 years unless the eye improved to mild NDPR or better.
Based on the main outcomes of the development of PDR or CI-DEM with vision loss (≥10 letters at 1 visit or ≥5 letters at 2 consecutive visits) and change in visual acuity (best corrected Early Treatment Diabetic Retinopathy Study letter score) from baseline to 4 years, the investigators found: “Among participants (mean age 56 years; 42.4% female; 5% Asian, 15% Black, 32% Hispanic, 45% White), the 4-year cumulative probability of developing PDR or CI-DME with vision loss was 33.9% with aflibercept vs 56.9% with sham (adjusted hazard ratio, 0.40 [97.5% CI, 0.28 to 0.57]; P < .001). The mean (SD) change in visual acuity from baseline to 4 years was −2.7 (6.5) letters with aflibercept and −2.4 (5.8) letters with sham (adjusted mean difference, −0.5 letters [97.5% CI, −2.3 to 1.3]; P = .52). Antiplatelet Trialists’ Collaboration cardiovascular/cerebrovascular event rates were 9.9% (7 of 71) in bilateral participants, 10.9% (14 of 129) in unilateral aflibercept participants, and 7.8% (10 of 128) in unilateral sham participants.”