Prophylactic aflibercept reduces vision-threatening complications without gains in visual acuity

Treatment with intravitreal aflibercept in patients with nonproliferative diabetic retinopathy (NPDR) but without centre-involved diabetic macular edema (CI-DME) appears to slow disease progression and reduce the risk of developing vision-threatening complications but fall short of improving visual acuity, according to a study.

The study included 328 adults (399 eyes; mean age 56 years, 42.4 percent women, 45 percent White) with moderate to severe NPDR (Early Treatment Diabetic Retinopathy Study [ETDRS] severity level 43–53) without CI-DME.

Eyes were randomly assigned to receive 2.0-mg aflibercept (n=200) or sham (n=199). A total of eight injections were given at defined intervals over 2 years, with treatment continued quarterly through 4 years unless NPDR improved and became mild or better.

At the 4-year follow-up, the cumulative probability of developing proliferative diabetic retinopathy or CI-DME with vision loss was 33.9 percent in the aflibercept group vs 56.9 percent in the sham group (adjusted hazard ratio, 0.40, 97.5 percent confidence interval [CI], 0.28–0.57; p<0.001).

However, there was no significant between-group difference in the mean change in visual acuity from baseline to 4 years (−2.7 letters with aflibercept vs −2.4 letters with sham; adjusted mean difference, −0.5 letters, 97.5 percent CI, −2.3 to 1.3; p=0.52).

The rates of Antiplatelet Trialists’ Collaboration cardiovascular/cerebrovascular events were 9.9 percent (seven of 71) in bilateral participants, 10.9 percent (14 of 129) in unilateral aflibercept participants, and 7.8 percent (10 of 128) in unilateral sham participants.

The findings do not warrant the use of aflibercept as a preventive strategy for patients with NPDR without CI-DME.