NIH-funded clinical trial results support ‘step therapy’ for treating DME

A recent DRCR Retina Network clinical trial examined a stepwise regimen of anti-VEGF drugs, bevacizumab and aflibercept.

Funded by the National Eye Institute (ENI) of the National Institutes of Health (NIH) and the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), a recent DRCR Retina Network clinical trial examined an anti-endothelial growth stage regimen. -vascular (VEGF) drugs bevacizumab and aflibercept.

The results of this trial, published in the New England Journal of Medicine, show that patients with diabetic macular edema (DME) can use a “stepped strategy”, starting with a cost-effective drug before progressing to a more expensive if the vision does not work. improve and the results are similar to those obtained by starting with the most expensive drug, according to a press release.

“Our study has shown that switching treatment when needed is a reasonable strategy,” said Chirag Jhaveri, MD, Austin Research Center for Retina, Texas, the study’s lead author said in the release. “Insurance companies often require clinicians to start with the least expensive treatment, so we really wanted to see how a specific treatment strategy using this approach would affect patient care.”

The main complication of DME, which is caused by diabetes-related damage to the retinal blood vessels, is fluid buildup in the retina, and it is usually treated with anti-VEGF drugs. Symptoms include blurred vision and, if left untreated, vision loss can be permanent and lead to blindness. Vision can be restored with retinal injections of anti-VEGF drugs.

The DRCR Retina Network has previously shown that bevacizumab and aflibercept improve visual acuity in people with DME; However, while aflibercept is approved by the US Food and Drug Administration (FDA) to treat DME and provides better visual outcomes, bevacizumab is much more cost effective and is sometimes required by insurers as a treatment for first intention.

“We have demonstrated here a method of managing a treatment in stages, where the results are similar to the best existing treatment protocol with [aflibercept]said Jennifer Sun, MD, MPH, of the Joslin Diabetes Center and Harvard Medical School, Boston, and Chair of Diabetes Initiatives for the DRCR Retina Network. “Anytime we can add to a clinician’s toolbox, whether it’s a new drug or a new approach to using existing drugs, in this study, that’s an advantage. for patients.”

The study

The study recruited 270 participants with diabetic macular edema (DME), some of whom received treatments in both eyes. At the time of enrollment, all had optimal visual acuity between 20/50 and 20/320.

At the start of the study, half of the eyes were assigned to aflibercept and the other half to bevacizumab. Participants who needed treatment in both eyes were assigned a different drug for each eye.

Study participants received bevacizumab or aflibercept injections every 4 weeks for 24 weeks. If eyes assigned to bevacizumab did not meet predefined improvement criteria from 12 weeks, the eye was switched to aflibercept.

After 24 weeks, doctors could reduce the frequency of injections as needed to maintain visual acuity, and the study collected information about participants’ retinal structure and visual acuity for 2 years.


After 2 years, the eyes of both groups had similar visual acuity results, improving on average by about 3 lines on an eye chart, compared to the start of the trial. In the bevacizumab group, 70% of eyes switched to aflibercept during the study.

“While most of the participants on [bevacizumab] eventually moved on to [aflibercept], they got even better in those first few weeks, even though they didn’t meet our predefined benchmarks, said Adam Glassman of the Jaeb Center for Health Research and director of the DRCR Retina Network Coordinating Center. “There are large cost disparities between these drugs, so differences in treatment strategies can have significant cost implications.”

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