Conditions: Age-Related Macular Degeneration
Keywords: Wet AMD choroidal neovascularization Fovista® E10030 Lucentis®
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 627
Healthy volunteers: no

Brief summary:
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).

Arms:
arm 1: E10030 1.5 mg intravitreal injection + ranibizumab 0.5 mg intravitreal injection arm 2: E10030 sham intravitreal injection + ranibizumab 0.5 mg intravitreal injection

Interventions: intervention 1: E10030 intervention 2: ranibizumab intervention 3: E10030 sham intravitreal injection
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: Pressure on the eye with a syringe with no needle

Protocol document: