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.

OPH1002

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).

2013-08-01

2016-12-01

2016-12-01

Terminated

Early phase I

619

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 619, 'type': 'ACTUAL'}}

2024-02-23