This trial is active, not recruiting.

Condition age-related macular degeneration
Treatments e10030, ranibizumab, e10030 sham intravitreal injection
Phase phase 3
Targets VEGF, PDGF
Sponsor Ophthotech Corporation
Start date August 2013
End date July 2016
Trial size 622 participants
Trial identifier NCT01940900, OPH1003


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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
E10030 1.5 mg intravitreal injection + ranibizumab 0.5 mg intravitreal injection
e10030 Fovista®
ranibizumab Lucentis®
(Active Comparator)
E10030 sham intravitreal injection + ranibizumab 0.5 mg intravitreal injection
ranibizumab Lucentis®
e10030 sham intravitreal injection Sham
Pressure on the eye with a syringe with no needle

Primary Outcomes

Mean Change in Visual Acuity from Baseline at the Month 12 Visit.
time frame: 12 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) 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

Additional Information

Official title A Phase 3 Randomized, Double-masked, Controlled Trial to Establish the Safety and Efficacy of Intravitreous Administration of Fovista® (Anti PDGF-B Pegylated Aptamer) Administered in Combination With Lucentis® Compared to Lucentis® Monotherapy in Subjects With Subfoveal Neovascular Age-related Macular Degeneration.
Description Subjects will be randomized in a 1:1 ratio to the following dose groups: - Fovista® 1.5 mg/eye + Lucentis® 0.5 mg/eye - Fovista® sham + Lucentis® 0.5 mg/eye Subjects will be treated for a total of 24 months with active Fovista® or sham in combination with Lucentis® with the primary endpoint at 12 months. Primary Efficacy Endpoint: The primary efficacy endpoint is the mean change in visual acuity (ETDRS letters) from baseline at the month 12 visit. Safety Endpoints: Safety endpoints include adverse events, vital signs, ophthalmic variables [ophthalmic examination, intraocular pressure (IOP), fluorescein angiogram (FA), optical coherence tomography (OCT)], ECG, and laboratory variables. Approximately 622 subjects will be randomized into one of the two treatment cohorts (311 patients per dose group).
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by Ophthotech Corporation.