Study: Early Anti-VEGF Treatment of Diabetic Retinopathy Slows Progression but Yields No Benefit to Visual Acuity

While early treatment of diabetes-related eye disease slowed progression to severe disease, it did not improve visual acuity compared with treating more severe disease once it developed, according to a clinical study from the DRCR Retina Network. The study was funded by the National Eye Institute (NEI), part of the National Institutes of Health.

“This study indicates that monitoring patients regularly for vision-threatening diabetes complications and treating eyes only as needed is the best approach,” Raj Maturi, MD, Indiana University School of Medicine and Retina Partners Midwest, who is the protocol chair for the 4-year study, said in a NIH news release. The report was published in the Journal of the American Medical Association (JAMA).

NEI-funded researchers evaluated whether treating people with non-proliferative diabetic retinopathy (NPDR) with the anti-VEGF drug Eylea (aflibercept) could prevent vision loss. The study enrolled 328 participants, with 399 study eyes (some participants had two eyes that met criteria for enrollment in the study; others only had one study-eligible eye). Preventive anti-VEGF injections were given in 200 eyes at 1 month after enrollment, 2 months, and 4 months, and then every 4 months over 2 years. Preventative treatment continued every 4 months through 4 years unless NPDR improved to only mild disease. Sham injections (without drug) were used in 199 eyes over the same period. Any eye that developed a vision-threatening complication, such as macular edema or PDR was treated with additional anti-VEGF injections as necessary. 

Two-year results of the study suggested that while preventive treatment reduced the risk of developing diabetic macular edema or PDR, there was no evident benefit to vision. These final, 4-year results reinforce the earlier finding, with no statistical difference in either visual acuity or rates of vision loss between the two groups. 

“We expected early treatment to prevent progression of diabetic retinopathy, but even with preventative injections, about one-third of eyes developed vision-threatening complications,” said Adam Glassman, Jaeb Center for Health Research, Tampa, Florida, who directs the DRCR Retina Network coordinating center.

Over the 4-year study, 34% percent of eyes receiving preventive treatments showed disease progression, compared with 57% of those in the sham group. On average, those in the preventive group received 11 injections, compared with an average of three in the sham group.

“While the individual risk of complications per injection is low, the risk increases with each additional injection,” said Jennifer Sun, MD, MPH, Joslin Diabetes Center, Harvard Medical School, Boston, and chair of diabetes initiatives for the DRCR Retina Network. “The results of this study indicate that the anatomic benefit from early anti-VEGF treatment does not result in improved visual acuity, and so it may not be worth the risk and inconvenience to the patient of repeat preventive injections for NPDR.”

The Clinicaltrials.gov identifier for this study is NCT02634333. 

Reference:

Maturi RK, Glassman AR, Josic K, et al. “Four-year visual outcomes in a randomized trial of intravitreous aflibercept for prevention of vision threatening complications of diabetic retinopathy (Protocol W).” JAMA. February 7, 2023.