A clinical study out of the DRCR Retina Network and published in JAMA investigated whether the use of aflibercept (Eylea), an anti-vascular endothelial growth factor (anti-VEGF) drug, for early treatment of diabetes-related eye diseases resulted in reduced or improved disease progression over time.
Tell me about the study.
Investigators conducted a randomized clinical trial at 64 sites in the U.S. and Canada. A total of 328 patients (399 eyes) were enrolled—all diagnosed with moderate-to-severe nonproliferative diabetic retinopathy (NPDR) without center-involved diabetic macular edema (CI-DME).
Patients randomly received eight injections of either 2.0 mg aflibercept (n = 200) or (n = 199) sham at one month, two months, four months, and then every four months over a 2-year period followed by quarterly injections through 4 years, unless the observed eye improved to mild NPDR or better.
What were the results?
Four-year data from all participants showed a cumulative 33.9% chance of developing PDR or CI-DME with aflibercept injection vs a 56.9% chance with sham (adjusted hazard ratio, 0.40 [97.5% CI, 0.28 to 0.57]; P < .001).
Visual acuity from baseline to 4 years reported a mean change of -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).
What does this mean?
The 2-year results suggest that despite a reduction in the risk for developing DME or PDR, there was no clear benefit of aflibercept as a preventative treatment for vision.
Based on the 4-year data, researchers reported no statistical difference in rates of vision loss or visual acuity between either patient groups.
Take home?
Study authors concluded that the anatomic benefits of aflibercept injections do not lead to improved visual acuity and, thus, the risk for a patient to receive such treatment for NPDR would not be an advantageous course of action.