HealthDay News — For eyes with nonproliferative diabetic retinopathy (NPDR), aflibercept injection is associated with a reduction in the proportion developing center-involved diabetic macular edema (CI-DME) with vision loss or high-risk proliferative diabetic retinopathy (PDR), according to a study published online March 30 in JAMA Ophthalmology.
Raj K. Maturi, MD, from the Midwest Eye Institute at the Indiana University School of Medicine in Indianapolis, and colleagues collected data for 328 adults (399 eyes) with moderate-to-severe NPDR without CI-DME. Eyes were randomly assigned to receive either intravitreous aflibercept injections or sham treatment (200 and 199, respectively) given at baseline, one, two, and four months, and every four months through two years.
The researchers found that the two-year cumulative probability of developing CI-DME with vision loss or PDR was 16.3 and 43.5 percent with aflibercept and sham, respectively, with an overall hazard ratio for either outcome of 0.32 (97.5 percent confidence interval, 0.21 to 0.50; P < 0.001). The two-year cumulative probability of developing PDR was 13.5 and 33.2 percent in the aflibercept and sham groups, respectively, while the corresponding two-year cumulative probability of developing CI-DME with vision loss was 4.1 and 14.8 percent. From baseline to two years, the mean change in visual acuity was −0.9 and −2.0 letters with aflibercept and sham, respectively (adjusted mean difference, 0.5 letters; 97.5 percent confidence interval, −1.0 to 1.9 letters; P = 0.47).
“While it is possible that preventive injections of anti-vascular endothelial growth factor drugs may help protect vision in the longer-term, we saw no effect on vision at two years,” Maturi said in a statement.
Several authors disclosed financial ties to pharmaceutical companies, including Regeneron, which provided aflibercept for the study and funds to defray the study’s clinical site costs.