A Phase II/III Multicenter, Randomized, Masked, Active Comparator-Controlled Study to Evaluate the Safety and Efficacy of Two Doses of OCUL101, an Anti-VEGF and Anti-Complement C5, Bi-specific Humanized Antibody-Like “trap” in Participants with Neovascular Age-Related Macular Degeneration with or without Geographic Atrophy – STAT Study

Condition studied

Neovascular age-related macular degeneration (nAMD)

Investigational medicinal product(s)

Eligibility

Primary endpoint

Part A: 1. The incidence and rate of adverse events (AEs), serious adverse events (SAEs), and treatment emergent adverse events (TEAEs)., Part B: 1. Change from Baseline in mean BCVA letters using the ETDRS chart at Week 36 vs. active control (aflibercept 2mg).

Endpoint detail

Part A: 1. Change from Baseline in mean BCVA using the ETDRS chart after three intravitreal injections, and at Week 16., 2. Change from Baseline in mean central subfield macular thickness (CST), as documented by spectral domain optical coherence tomography (SD-OCT) after three intravitreal injections, to Week 96., Part B: 1. Mean change from Baseline in CST, as documented by SD-OCT vs. aflibercept 2mg at Week 36., 2. Proportion of participants with ≥15-letter improvement in BCVA from Baseline as measured by ETDRS chart at Week 36 vs. aflibercept 2mg., 3. Percent change in CNV lesion size (mm2) vs. aflibercept at Week 96 by fluorescein angiography (FA) and color fundus photography (CFP)., 4. Change in square root of geographic atrophy (GA) lesion size (mm2) at Week 96 by fundus autofluorescence (FAF).