Preventive treatment reduces complications of diabetic retinopathy

Press release

Wednesday March 31, 2021

In a clinical trial, early treatment with anti-vascular endothelial growth factor (VEGF) injections slowed diabetic retinopathy, a complication of diabetes that damages blood vessels in photosensitive tissues in the retina. However, two years after the start of the four-year study, the effect of early treatment on vision – including changes in visual acuity and vision loss – was similar to standard treatment, which usually does not begin. only after the onset of late disease. Interim results from the DRCR Retina Network (DRCR.net) published today in JAMA Ophthalmology. The study was supported by the National Eye Institute (NEI), which is part of the National Institutes of Health.

“While it is possible that preventative injections of anti-VEGF drugs may help protect long-term vision, we have not seen any effect on vision at two years,” said Raj Maturi, MD, Indiana University. , Indianapolis, chairman of protocol for the study. “These two-year results suggest that close monitoring and routine treatment for complications are essential to prevent vision loss from diabetic retinopathy.”

An estimated 30 million Americans have diabetes, which can cause blood vessel abnormalities, including the growth of new blood vessels in the eyes. In the early stages of diabetic retinopathy, called diabetic nonproliferative retinopathy, changes to the blood vessels in the eye are visible to clinicians but usually do not affect sight. In later stages, people may develop proliferative diabetic retinopathy, where retinal blood vessels grow abnormally, and / or diabetic macular edema, where fluid leaks from retinal blood vessels. Both can lead to vision loss and blindness. Treatment, such as anti-VEGF drugs, can slow or prevent vision loss in people with proliferative diabetic retinopathy or diabetic macular edema, if treatment is started quickly.

In this study, participants with nonproliferative diabetic retinopathy were initially randomized to receive either Eylea injections (aflibercept) or a sham injection. They were seen at one, two, and four months, then every four months for two years, receiving Eylea or a sham injection at each visit. The researchers monitored their visual acuity and the severity of their diabetic retinopathy. If the disease progressed, whether in the treatment group or in the sham group, participants received Eylea more frequently as is given in standard practice. If their condition did not improve with additional anti-VEGF treatment, participants could receive treatments such as laser photocoagulation or surgery as needed.

The study included 328 participants (399 eyes). In two years, the rate of development of proliferative diabetic retinopathy was 33% in the control group, compared to 14% in the treatment group. Likewise, the rate of development of diabetic macular edema affecting vision was 15% in the control group, compared to 4% in the treatment group. However, the loss of visual acuity was essentially the same between the two groups at two years, suggesting that standard treatment at the onset of proliferative diabetic retinopathy or diabetic macular edema affecting vision is sufficient. to prevent further vision loss at this time.

“We have a very good treatment for these diseases, so we can manage the vision complications that can arise as the disease progresses for many eyes,” said Adam Glassman, Jaeb Center for Health Research, Tampa, Fla. director of the DRCR.net coordination center. “When evaluating new preventive treatment strategies, it is important to compare them directly to standard treatment after the disease worsens, as we did in this study.”

“While we haven’t seen any difference in visual results at two years, the four-year follow-up will be very important,” said Jennifer Sun, MD, MPH, Joslin Diabetes Center, Harvard Medical School, Boston, president of Initiatives on diabetes for the network. “We are looking at the data over four years to see if reducing the rates of worsening diabetic retinopathy will lead to long-term improvement in visual outcomes.”

The Clinicaltrials.gov ID for this study is NCT02634333. The study was supported by NEI and the National Institute of Diabetes and Digestive and Kidney Diseases, with funding through the Special Diabetes Program, under a cooperative agreement (EY14231). Regeneron provided an aflibercept for the study and funds to the DRCR Retina Network to cover the costs of the clinical site for the study. JDRF also provided funds to cover the costs of the clinical sites.

NEI leads federal government research on the visual system and eye disease. NEI supports basic and clinical science programs to develop treatments that save sight and meet the special needs of people with vision loss. For more information, visit https://www.nei.nih.gov.

About the National Institutes of Health (NIH):NIH, the country’s medical research agency, comprises 27 institutes and centers and is a component of the US Department of Health and Human Services. The NIH is the principal federal agency that conducts and supports basic, clinical, and translational medical research, and studies the causes, treatments, and cures for common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

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