Conditions: Age-Related Macular Degeneration
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 449
Healthy volunteers: no

Brief summary:
The objectives of this study are to evaluate the safety and efficacy of E10030 intravitreous injection when administered in combination with Lucentis® against a control of Lucentis® alone in subjects with subfoveal choroidal neovascularization secondary to age-related macular degeneration (AMD).

Detailed description:
Subjects will be randomized in a 1:1:1 ratio to the following dose groups:

* E10030 0.3 mg/eye + Lucentis® 0. 5 mg/eye
* E10030 1.5 mg/eye + Lucentis® 0. 5 mg/eye
* E10030 sham + Lucentis® 0. 5 mg/eye

Subjects will be treated with active E10030 or sham E10030 in combination with Lucentis® at Day 0, Week 4, Week 8, Week 12, Week 16 and Week 20.

Primary Efficacy Endpoint:

The primary efficacy endpoint is mean change in visual acuity from baseline at the Week 24 visit

Safety Endpoints:

Safety endpoints include adverse events, vital signs, ophthalmic variables \[visual acuity, intraocular pressure (IOP), ophthalmic examination, color fundus photography, fluorescein angiograms (FA), optical coherence tomography (OCT)\], and laboratory variables.

Approximately 444 subjects will be randomized into one of the three treatment cohorts (approximately 148 patients per dose group).

Arms:
arm 1: None arm 2: None arm 3: None

Interventions: intervention 1: E10030 plus Lucentis intervention 2: Lucentis
Intervention descriptions: intervention 1: once a month intravitreal injection intervention 2: 10 mg/mL intravitreal injection monthly

Protocol document: