Preventive Value of Aflibercept Questioned in NPDR Without CI-DME

Anatomic improvement, but no improvement in visual acuity, reported with aflibercept given for 4 years versus sham.

HealthDay News — Treatment with aflibercept vs sham, initiating aflibercept only if vision-threatening complications develop, yields anatomic improvement but no improvement in visual acuity for patients with nonproliferative diabetic retinopathy (NPDR) without center-involved diabetic macular edema (CI-DME), according to a study published in the February 7 issue of the Journal of the American Medical Association.

Raj K. Maturi, MD, from the Midwest Eye Institute in Indianapolis, and colleagues compared the primary 4-year outcomes of visual acuity and rates of vision-threatening complications in 399 eyes from 328 adults with moderate-to-severe NPDR without CI-DME treated with intravitreal aflibercept vs sham. The eyes were randomly assigned to aflibercept or sham (200 and 199, respectively); through two years, eight injections were administered and continued quarterly through four years unless the eye improved to mild NPDR or better. In both groups, aflibercept was given to treat development of high-risk proliferative diabetic retinopathy (PDR) or CI-DME with vision loss.

The researchers found that the 4-year cumulative probability of developing PDR or CI-DME with vision loss was 33.9 with aflibercept and 56.9% with sham (adjusted hazard ratio, 0.40). From baseline to 4-years, the mean change in visual acuity was –2.7 and 2.4 letters with aflibercept and sham, respectively (adjusted mean difference, 0.5 letters).

“Given no established meaningful visual acuity advantage, this trial does not support earlier treatment for severe NPDR, at least up to four years,” the authors write.

Several authors disclosed ties to the pharmaceutical industry.

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