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Phase 2 VEGF Trap-Eye study shows positive visual results in DME patients
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TARRYTOWN, N.Y. — In a phase 2 clinical trial, VEGF Trap-Eye statistically significantly improved visual acuity among patients with diabetic macular edema, according to a joint press release from co-developers Regeneron Pharmaceuticals and Bayer HealthCare.
The prospective, double-masked, randomized, multicenter DA VINCI (DME and VEGF Trap-Eye: investigation of clinical impact) trial enrolled 219 patients with clinically significant DME involving the central macula who were randomly assigned to one of five groups. The control group received macular laser therapy at 1 week, and patients were eligible to receive laser treatment at a minimum of 16-week intervals. In addition, two groups received monthly doses of either 0.5 mg or 2 mg of VEGF Trap-Eye for 6 months, and two groups received 2-mg doses of VEGF Trap-Eye at baseline and at 1 and 2 months, followed by either 8-week or as-needed dosing through 24 weeks.
At 24 weeks, the investigators found that patients in each of the four groups receiving VEGF Trap-Eye achieved statistically significantly greater improvements in visual acuity — gaining between 8.5 and11.4 letters — compared to patients receiving macular laser therapy(2.5 letters; P < .01 for each VEGF Trap-Eye group vs. laser), according to the release.
VEGF Trap-Eye was generally well tolerated, and there were no serious drug-related adverse events.
Regeneron and Bayer plan to release preliminary 1-year results for the DA VINCI study later this year.
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