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).
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
449
once a month intravitreal injection
10 mg/mL intravitreal injection monthly
Palmetto Retinal Center
West Columbia, South Carolina, United States
Mean Change in Visual Acuity From Baseline at the Week 24 Visit
The primary efficacy endpoint is the mean change in visual acuity from baseline at the Week 24 visit
Time frame: 24 Weeks
The Proportion of Subjects Gaining 15 or More ETDRS Letters From Baseline at the Week 24 Visit
The proportion of subjects gaining 15 or more ETDRS letters from baseline at the Week 24 visit
Time frame: 24 weeks
Proportion of Patients With at Least 1 Adverse Event
Time frame: 24 weeks
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