This trial has been terminated.

Condition age-related macular degeneration
Treatments fovista®, bevacizumab, ranibizumab, aflibercept
Phase phase 2
Targets VEGF, PDGF
Sponsor Ophthotech Corporation
Start date February 2015
End date March 2017
Trial size 64 participants
Trial identifier NCT02387957, OPH1006


To evaluate the safety of intravitreal (IVT) Fovista® administered in combination with anti-VEGF therapy.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Primary purpose treatment
Masking no masking
Fovista® 1.5 mg intravitreal injection + bevacizumab 1.25 mg intravitreal injection
bevacizumab Avastin®
Fovista® 1.5 mg intravitreal injection + 0.5 mg ranibizumab intravitreal injection
ranibizumab Lucentis®
Fovista® 1.5 mg intravitreal injection + 2.0 mg aflibercept intravitreal injection
aflibercept Eylea®

Primary Outcomes

To evaluate the safety of Fovista (anti-PDGF BB) when administered in combination with anti-VEGF therapy as assessed by the incidence of test article related adverse events
time frame: 18 Months

Eligibility Criteria

All participants at least 50 years old.

Inclusion Criteria: - Subjects of either gender aged ≥ 50 years. - Active subfoveal choroidal neovascularization (CNV) due to AMD. 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.

Additional Information

Description 60 subjects randomized 1:1:1 and treated with IVT Fovista® 1.5 mg/eye in combination with anti-VEGF therapy as follows: - Avastin® 1.25 mg/eye (20 subjects) - Lucentis® 0.5 mg/eye (20 subjects) - Eylea® 2.0 mg/eye (20 subjects) Subjects will be stratified by lesion size (≤2 DA vs. >2 DA). Subjects will be treated with "combination therapy" of IVT Fovista® and IVT anti-VEGF therapy every month for the first 5 months (Day 1, Months 1,2,3,4), followed by Q12W (every 12 weeks) administration (Months 7,10, 13, and 16), for a total of 18 months. When administered, IVT Fovista® will be given first, followed by IVT anti-VEGF (same day).
Trial information was received from ClinicalTrials.gov and was last updated in January 2017.
Information provided to ClinicalTrials.gov by Ophthotech Corporation.