Regeneron and Bayer HealthCare have initiated a Phase III clinical to evaluate the efficacy and safety of VEGF Trap-Eye (aflibercept ophthalmic solution) in patients with myopic choroidal neovascularisation.
The trial, which is being conductedin collaboration with the Singapore Eye Research Institute, will enrol around 250 patients across Japan, Singapore, China, Korea and Taiwan, and is scheduled to run until June 2013.
Three out of four trial participants will be given an injection of VEGF Trap-Eye in the affected eye, while the remainder with be given a placebo procedure.
The primary outcome measure of the study is the mean change in vision after 24 weeks compared to baseline.
Secondary outcome measures include percentage of patients who gain or lose certain amounts of letters in a visual test, changes in retinal thickness from baseline, changes in the total lesion size and vessel leakage as observed on an angiogram of the affected eye.
VEGF Trap-Eye is a fully human fusion protein. It contains soluble VEGF receptors 1 and 2, that binds all forms of VEGF-A and the related placental growth factor.
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Myopic choroidal neovascularisation is of the retina that causes abnormal blood vessels grow in individuals who are severely myopic and have pathological changes in the back of the eye.