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Regeneron and Bayer HealthCare launch phase 3 trial with Singapore Eye Research Institute
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TARRYTOWN, N.Y. — Regeneron and Bayer HealthCare have launched a phase 3 clinical trial in collaboration with the Singapore Eye Research Institute, or SERI, evaluating VEGF Trap-Eye among Asian patients with myopic choroidal neovascularization, the companies announced in a joint press release.
The trial has already started in Japan and will include patients from Singapore, China, Korea and Taiwan later in the year. SERI, the Singapore national research institute for ophthalmic and vision research, will serve as the Asian reading center partner for the study.
The study will enroll 250 patients and continue until June 2013. For the first 24 weeks, 75% of patients will receive injections of VEGF Trap-Eye (aflibercept ophthalmic solution) into the affected eye and repeated injections if required, while 25% of patients will receive sham treatment. After 24 weeks, both groups will be assessed by a team of doctors, and the patients who received sham treatments will begin active injections, according to the release.
The trial will primarily evaluate the mean change in vision after 24 weeks.
Myopia is one of the most prevalent eye conditions in Asian populations, where approximately 40% of adults in Singapore have myopia and nearly 10% have high myopia, according to the release.