Overview

A Phase 3 Safety and Efficacy Study of Fovista® (E10030) Intravitreous Administration in Combination With Lucentis® Compared to Lucentis® Monotherapy

Status:
Terminated
Trial end date:
2016-12-01
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Ophthotech Corporation
Treatments:
Ranibizumab
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