Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Regeneron and Bayer HealthCare have initiated a Phase III clinical trial in collaboration with the Singapore Eye Research Institute (SERI), evaluating the efficacy and safety of VEGF Trap-Eye (aflibercept ophthalmic solution) in patients with myopic choroidal neovascularisation (mCNV).
Subscribe to our email newsletter
The Phase III trial will enroll approximately 250 patients across Japan, Singapore, China, Korea, and Taiwan, and is scheduled to run until June 2013.
In the trial, three out of four patients will receive an injection of VEGF Trap-Eye into the affected eye, while one out of four patients will receive a sham procedure.
The primary outcome measure of the study is the mean change in vision after 24 weeks, compared to baseline.
The secondary outcome measures include percentage of patients who gain or lose certain amounts of letters in the visual test, changes in retinal thickness from baseline, changes in the total mCNV lesion size, and vessel leakage as seen on an angiogram of the affected eye.
VEGF Trap-Eye is a fully human fusion protein, which contains soluble VEGF receptors 1 and 2, that binds all forms of VEGF-A along with the related Placental Growth Factor (PlGF).