Clinical Trial


A Phase 3 Safety and Efficacy Study of Fovista® (E10030) Intravitreous Administration in Combination With Lucentis® Compared to Lucentis® Monotherapy


Brief description

The objectives of this study are to evaluate the safety and efficacy of intravitreal administration of Fovista® administered in combination with Lucentis® compared to Lucentis® monotherapy in subjects with subfoveal choroidal neovascularization secondary to age-related macular degeneration (AMD).

Detailed 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 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).

Keywords

  •   Age-Related Macular Degeneration

Sponsored By

Ophthotech Corporation

Unique Study ID

NCT01944839

Investigators and Research Sites Near You - Found( 3 )

No Investigator Listed

Sanofi
85013, Phoenix, Arizona, United States
Distance from Current Trial is 0 miles

No Investigator Listed

Takeda
85013, Phoenix, Arizona, United States
Distance from Current Trial is 0 miles

Sanjay Shah, MD

Global Blood Therapeutics
85016, Phoenix, Arizona, United States
Distance from Current Trial is 0 miles
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