Patients with moderate to severe nonproliferative diabetic retinopathy — which occurs when diabetes damages blood vessels in the retina — who received early therapeutic intervention with anti-VEGF medication injections saw no improvement in their visual acuity compared to patients who underwent sham treatment, according to a recent clinical trial published in JAMA.
“This means that a large number of patients do not have to be treated prophylactically and many of those will not have to be treated at all. Watchful waiting was just as good as immediate initiation of therapy. This saves money and patient’s and physician’s time and effort,” said Lee Jampol, MD, the Louis Feinberg, MD, Professor of Ophthalmology and a co-author of the study.
Diabetic retinopathy is the leading cause of blindness in adults, but the disease can be treated by controlling a patient’s blood sugar level, blood pressure and cholesterol levels through medications and lifestyle modifications. Laser eye treatments, such as a focal laser and panretinal photocoagulation, can also be effective, as well as directly injecting the eye with anti-VEGF medications, which decrease blood vessels from leaking and bleeding, which can cause severe damage.
For patients with severe cases of diabetic retinopathy, effective treatments include panretinal photocoagulation or anti-VEGF injections. However, it had remained understudied whether patients with pre-proliferative diabetic retinopathy – those who were only beginning to show marked damage to the retina – would actually benefit from earlier anti-VEGF injections.
In the randomized clinical trial, more than 300 patients from clinical sites across the U.S. and Canada who were diagnosed with pre-proliferative diabetic retinopathy received either a placebo (until severe changes occurred and are then treated) or anti-VEGF injections (aflibercept) every four months for two years.
By the end of the study period, patients in both groups demonstrated similar long-term outcomes, with the same overall visual acuity. The findings suggest that earlier therapeutic intervention for these patients is unnecessary and provides no added benefit.
“We believe that a reasonable approach in most patients is not to initiate therapy for this earlier stage, pre-proliferative retinopathy, instead waiting for the development of diabetic macular edema or proliferative diabetic retinopathy and then initiating treatment,” Jampol said. “The interventions of laser and anti-VEGF therapy are costly, time consuming and do not always work. We are therefore looking for better preventative therapeutic options.”
This work was supported through a cooperative agreement from the National Eye Institute and the National Institute of Diabetes and Digestive and Kidney Diseases, the National Institutes of Health, and the U.S. Department of Health and Human Services (EY14231).