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Regeneron, Bayer launch phase 3 trial of novel VEGF agent for treatment of DME
TARRYTOWN, N.Y. — Regeneron Pharmaceuticals and Bayer HealthCare have initiated the first of two phase 3 clinical trials to evaluate VEGF Trap-Eye in the treatment of diabetic macular edema, the companies announced in a joint press release.
Bayer has already begun the first trial in Australia and is expected to conduct trials in Europe and Japan.
The VIVID-DME study has three study arms and will compare two doses of VEGF Trap-Eye (aflibercept ophthalmic solution) with macular laser photocoagulation. Patients will be followed for 3 years, and the primary outcome of the study will be change in visual acuity from baseline, the release said.
Regeneron will begin a second study, called VISTA-DME, in the United States, Canada and other countries later in 2011.
In late 2010, the companies announced positive data for VEGF Trap-Eye in patients with wet AMD and central retinal vein occlusion.