Bayer HealthCare and Regeneron Pharmaceuticals have initiated the first of two Phase III trials evaluating the safety and efficacy of VEGF Trap-Eye (aflibercept ophthalmic solution) in the treatment of diabetic macular oedema.
The trial will be conducted in Australia, Europe and Japan, and will have three study arms.
In the first arm, patients will be treated every month with 2mg of VEGF Trap-Eye. In the second, patients will be treated with 2mg of VEGF Trap-Eye every two months after a loading phase of monthly injections, while in the third, the comparator arm, patients will be treated with macular laser photocoagulation.
The primary endpoint will be a mean change in visual acuity from baseline as measured by the Early Treatment Diabetic Retinopathy Study (ETDRS) eye chart, a standard chart used in research to measure visual acuity.
All patients will be followed for three years.
A second Phase III trial of VEGF Trap-Eye is expected to begin later in 2011 in the US, Canada and other countries.
Diabetic macular oedema is a common complication of diabetic retinopathy, a disease affecting the blood vessels of the retina, and is the most prevalent cause of moderate vision loss in patients with diabetes.