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

Ophthotech

Status and phase

Terminated

Phase 2

Conditions

Age-related Macular Degeneration

Treatments

Drug: Fovista® (anti-PDGF BB) plus anti-VEGF

Study type

Interventional

Funder types

Industry

Identifiers

NCT02214628

OPH1005

Details and patient eligibility

About

The objective is to evaluate the safety of intravitreal Fovista® (anti-PDGF BB) administered in combination with anti-VEGF therapy.

Full description

The objective is to evaluate the safety of intravitreal Fovista® (anti-PDGF BB) administered in combination with anti-VEGF therapy in either a "Simultaneous" Regimen (Fovista® administered with anti-VEGF same day) or "Pre-Treatment" Regimen (monotherapy Fovista® Day 0 followed by Fovista® administered in combination with anti-VEGF Day 2).

Enrollment

101 patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

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