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.
Overview
- Phase
- Phase 3
- Intervention
- E10030
- Conditions
- Age-Related Macular Degeneration
- Sponsor
- Ophthotech Corporation
- Enrollment
- 619
- Primary Endpoint
- Mean Change in Visual Acuity From Baseline to 12 Months
- Status
- Terminated
- Last Updated
- last year
Overview
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).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects of either gender aged ≥ 50 years
- •Active subfoveal choroidal neovascularization (CNV) secondary to AMD
- •Presence of sub-retinal hyper-reflective material (SD-OCT)
Exclusion Criteria
- •Any prior treatment for AMD in the study eye prior to the Day 1 visit, except oral supplements of vitamins and minerals
- •Any prior intravitreal treatment in the study eye prior to the Day 1 visit, regardless of indication (including intravitreal corticosteroids)
- •Any intraocular surgery or thermal laser within three (3) months of trial entry. Any prior thermal laser in the macular region, regardless of indication
- •Subjects with subfoveal scar or subfoveal atrophy are excluded
- •Diabetes mellitus
Arms & Interventions
E10030 + ranibizumab
E10030 1.5 mg intravitreal injection + ranibizumab 0.5 mg intravitreal injection
Intervention: E10030
E10030 + ranibizumab
E10030 1.5 mg intravitreal injection + ranibizumab 0.5 mg intravitreal injection
Intervention: ranibizumab
Sham + ranibizumab
E10030 sham intravitreal injection + ranibizumab 0.5 mg intravitreal injection
Intervention: ranibizumab
Sham + ranibizumab
E10030 sham intravitreal injection + ranibizumab 0.5 mg intravitreal injection
Intervention: E10030 sham intravitreal injection
Outcomes
Primary Outcomes
Mean Change in Visual Acuity From Baseline to 12 Months
Time Frame: 12 Months
The primary efficacy endpoint is the mean change in visual acuity (ETDRS letters) from baseline to the month 12 visit. Higher ETDRS letters represents higher vision and a higher change in ETDRS letters represents better functioning.