Overview

Phase 2A Open Label Safety Study of Fovista® (Anti-PDGF BB) Regimen Administered in Combination With Anti-VEGF Therapy to Study Sub-Retinal Fibrosis in Neovascular AMD

Status:
Terminated
Trial end date:
2016-12-01
Target enrollment:
0
Participant gender:
All
Summary
The objective is to evaluate the safety of intravitreal Fovista® (anti-PDGF BB) administered in combination with anti-VEGF therapy.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Ophthotech Corporation
Treatments:
Bevacizumab
Platelet-derived growth factor BB
Criteria
Inclusion Criteria:

- Subjects of either gender aged ≥ 50 years

- All fluorescein angiographic subtypes with presence of active choroidal
neovascularization

Exclusion Criteria:

- 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

- Any ocular or periocular infection in the past twelve (12) weeks

- History of any of the following conditions or procedures in the study eye:
Rhegmatogenous retinal detachment, pars plana vitrectomy, filtering surgery (e.g.
trabeculectomy), glaucoma drainage device, corneal transplant