Regeneron, Bayer initiate phase III SIGHT trial in China

Monday, November 28, 2011 10:30 AM

Regeneron Pharmaceuticals and Bayer HealthCare have initiated a phase III clinical trial evaluating the efficacy and safety of EYLEA (aflibercept) injection in the neovascular form of age-related macular degeneration (wet AMD) in China.

The trial, named SIGHT, will include approximately 300 patients and
will be the largest retinal trial conducted in China. SIGHT is being led
by Bayer.

The SIGHT (VEGF Trap-Eye: Investigation of efficacy and safety in Chinese patients with wet AMD) program consists of a randomized, double-masked,
phase III clinical trial evaluating EYLEA (known in the scientific literature as VEGF Trap-Eye) in the treatment of the neovascular form of age-related macular degeneration (wet AMD).  EYLEA will be evaluated for its effect on improving and maintaining vision when dosed as an intravitreal injection on a schedule of 2 mg every two months (following three initial monthly doses), as compared with Photodynamic Therapy (PDT) with verteporfin. After assessment of the primary endpoint at week 28, all patients, including those on PDT, will receive EYLEA
treatment until the end of the study at week 52.

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