A Phase 3 Randomized, Double-masked, Controlled Trial to Establish the Safety and Efficacy of Intravitreous Administration of Fovista® (Anti PDGF-B Pegylated Aptamer) Administered in Combination With Lucentis® Compared to Lucentis® Monotherapy in Subjects With Subfoveal Neovascular Age-related Macular Degeneration.

Descripción detallada

Subjects will be randomized in a 1:1 ratio to the following dose groups: * Fovista® 1.5 mg/eye + Lucentis® 0.5 mg/eye * Fovista® sham + Lucentis® 0.5 mg/eye Subjects will be treated for a total of 24 months with active Fovista® or sham in combination with Lucentis® with the primary endpoint at 12 months. Primary Efficacy Endpoint: The primary efficacy endpoint is the mean change in visual acuity (ETDRS letters) from baseline at the month 12 visit. Safety Endpoints: Safety endpoints include adverse events, vital signs, ophthalmic variables \[ophthalmic examination, intraocular pressure (IOP), fluorescein angiogram (FA), optical coherence tomography (OCT)\], ECG, and laboratory variables. Approximately 622 subjects will be randomized into one of the two treatment cohorts (311 patients per dose group).