Research Title: 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.
Sponsor: Ophthotech Corporation
Principal Investigator: Atul Sharma, M.D.
Description: 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 activity (ETDRS letters) from baseline at the month 12 visit.
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).
Start Date: November 2013
Project Personnel: Leslie Marcus, CCRC
Location(s): Marietta; 833 Campbell Hill Street, Suite 300, Marietta, GA 30060