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 Either Avastin® or Eylea® Compared to Avastin® or Eylea® Monotherapy in Subjects With Subfoveal Neovascular Age-related Macular Degeneration.
Overview
- Phase
- Phase 3
- Intervention
- bevacizumab or aflibercept
- Conditions
- Age-Related Macular Degeneration
- Sponsor
- Ophthotech Corporation
- Enrollment
- 645
- Primary Endpoint
- Mean Change in Visual Acuity (Measured at Baseline and at the Month 12 Visit)
- 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 either Avastin® or Eylea® compared to Avastin® or Eylea® 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 two arms per study design: * Fovista® 1.5 mg/eye + Avastin® 1.25 mg/eye or Eylea® 2 mg/eye * Fovista® sham + Avastin® 1.25 mg/eye or Eylea® 2 mg/eye Subjects will be treated for up to 24 months with active Fovista® or sham, in combination with either Avastin® or Eylea® with the primary endpoint at 12 months. Approximately 622 subjects will be randomized into one of the two treatment groups (311 patients per dose group), and the efficacy analysis will be based on the data from these two groups as per the SAP
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 + bevacizumab or aflibercept
E10030 1.5 mg intravitreal injection + bevacizumab 1.25 mg intravitreal injection or aflibercept 2 mg intravitreal injection
Intervention: bevacizumab or aflibercept
E10030 + bevacizumab or aflibercept
E10030 1.5 mg intravitreal injection + bevacizumab 1.25 mg intravitreal injection or aflibercept 2 mg intravitreal injection
Intervention: E10030
Sham + bevacizumab or aflibercept
E10030 sham injection + bevacizumab 1.25 mg intravitreal injection or aflibercept 2 mg intravitreal injection
Intervention: bevacizumab or aflibercept
Sham + bevacizumab or aflibercept
E10030 sham injection + bevacizumab 1.25 mg intravitreal injection or aflibercept 2 mg intravitreal injection
Intervention: E10030 sham injection
Outcomes
Primary Outcomes
Mean Change in Visual Acuity (Measured at Baseline and at the Month 12 Visit)
Time Frame: 12 months
The primary efficacy endpoint is the mean change in visual acuity (ETDRS letters) measured at baseline and at the month 12 visit. Higher ETDRS letters represents higher vision and a higher change in ETDRS letters represents better functioning.