Ophthalmic Txs for DME Compared in NIH-Funded Study
Treatment with Eylea (aflibercept; Regeneron) led to greater average visual improvement than Avastin (bevacizumab; Genentech) or Lucentis (ranibizumab; Genentech) when vision was 20/50 or worse at treatment initiation but similar improvement when the starting vision was 20/40–20/32, according to data from a clinical trial funded by the National Eye Institute (NEI), which is part of the National Institutes of Health (NIH). Findings from the study are published in the New England Journal of Medicine.
Investigators from the Diabetic Retinopathy Clinical Research Network (DRCR.net) enrolled 660 patients with macular edema across 88 clinical trial sites. At initiation, patients had type 1 or type 2 diabetes for about 17 years. Patients were randomized to receive Eylea 2mg/0.05mL, Avastin 1.25mg/0.05mL, or Lucentis 0.3mg/0.05mL intravitreal injections until the diabetic macular edema (DME) resolved or stabilized. Also, laser treatment was administered for persistent DME without continual improvement after six months of injections.
The majority of patients experienced substantial improvement in their vision one year after treatment initiation. For patients with visual acuity of 20/32 or 20/40 at the start of trial, vision improvement was an average of almost two lines on an eye chart for all three study groups. For patients with visual acuity of 20/50 or worse at the start of trial, Eylea improved an average of almost four lines compared to an average of three lines with Lucentis, and 2.5 lines with Avastin. In addition, 36% of patients from the Eylea group underwent laser treatment for persistent DME vs. 56% from the Avastin group and 46% from the Lucentis group.
In a statement from Genentech, the company said they looked forward to better understanding the full one-year Protocol T data and whether differences in baseline characteristics influenced study results, particularly in patients with worse vision.
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