DME study: Aflibercept injection shows greater gains in visual acuity than alternative anti-VEGF therapies

March 24, 2015

In patients with moderate or worse vision loss at baseline, those treated with aflibercept (Eylea, Regeneron) Injection gained, on average, an additional full line or more on an eye chart when compared to those treated with alternative anti-VEGF therapies, according to a study published in the New England Journal of Medicine.

In patients with moderate or worse vision loss at baseline, those treated with aflibercept (Eylea, Regeneron) Injection gained, on average, an additional full line or more on an eye chart when compared to those treated with alternative anti-VEGF therapies, according to a study published in the New England Journal of Medicine.

Results from the National Institutes of Health (NIH)-sponsored, Diabetic Retinopathy Clinical Research Network comparative effectiveness study in patients with Diabetic Macular Edema (DME) (Protocol T) study compared the 3 most commonly used anti-VEGF drugs for the treatment of DME. All 3 drugs-aflibercept, bevacizumab (Avastin, Genentech), and ranibizumab (Lucentis, Genentech)-improved the vision in patients. In patients with worse visual acuity (20/50 or worse), aflibercept was more effective than either bevacizumab or ranibizumab. In those with good vision (20/40 or better), all 3 drugs worked equally well. There were no differences in safety between the drugs.

The Protocol T study was a prospective, comparative effectiveness trial supported by the National Eye Institute (a part of the NIH). More than 600 patients were randomly assigned to the 3 different treatments: aflibercept, 2 mg; bevacizumab, 1.25 mg, or ranibizumab, 0.3 mg dosed according to a protocol-specified algorithm. Patients were treated with focal/grid laser at or after the 24-week visit if: 1) the OCT central subfield thickness was greater than or equal to 250 microns or there was edema that was threatening the fovea and 2) the eye did not improve on OCT or visual acuity from the last 2 consecutive injections. Retreatment was based on visual acuity and the presence of DME on optical coherence tomography.

The primary outcome was visual acuity change at 1 year. There were a variety of secondary outcomes including change in OCT, number of injections given, and safety parameters.  The study has a second year, which is currently ongoing.

In the past, it has been assumed that all 3 anti-VEGF medications are relatively equivalent,” said John W. Kitchens, Retina Associates of Kentucky.

“However, until the DRCR Protocol T study, there has not been a study comparing all 3 drugs directly. In addition, there are few large, randomized trials utilizing a PRN-as needed-regimen,” Dr Kitchens said. “This study suggests that there is a difference in the treatments especially for patients with worse vision [20/50 or poorer vision]. These key differences are important for decision makers as not all of these medications are equally effective in all settings.

Related:FDA approves Lucentis for treatment of diabetic retinopathy in people with DME

“Understanding this will allow for a better understanding of when and why a retina specialist requests a particular medication for a patient,” he continued. “As a result, this can improve patient outcomes and potentially reduce the frequency of treatments.”

Related: Comparing anti-VEGs for DME

DME or "swelling of the macula" is a common complication in the eyes of patients with diabetes. It is the most frequent cause of vision loss in patients with diabetes and eventually can lead to blindness. It is estimated that of the 29.1 million American adults living with diabetes, 1.5 million have been diagnosed with DME, and approximately another million cases are undiagnosed.

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