Overview

This trial is active, not recruiting.

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

Summary

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
Endpoint classification safety study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Fovista® 1.5 mg intravitreal injection + bevacizumab 1.25 mg intravitreal injection
fovista®
bevacizumab Avastin®
(Experimental)
Fovista® 1.5 mg intravitreal injection + 0.5 mg ranibizumab intravitreal injection
fovista®
ranibizumab Lucentis®
(Experimental)
Fovista® 1.5 mg intravitreal injection + 2.0 mg aflibercept intravitreal injection
fovista®
aflibercept Eylea®

Primary Outcomes

Measure
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

Male or female 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 April 2016.
Information provided to ClinicalTrials.gov by Ophthotech Corporation.