A Phase 3 Clinical Trial to Compare Efficacy, Safety, Tolerability and Immunogenicity of RBS-001 to Eylea® in Subjects With Neovascular Age-Related Macular Degeneration
Rophibio, Inc.
Summary
This clinical study is designed to demonstrate the equivalence of the two Investigational Products by comparing the efficacy, safety, tolerability and immunogenicity of RBS-001 and Eylea® in subjects with Neovascular age-related macular degeneration.
Description
This is a phase 3 clinical trial to compare efficacy, safety, tolerability and immunogenicity of RBS-001 to Eylea® in subjects with neovascular age-related macular degeneration. A total of 434 subjects will be enrolled in the sponsor-selected study institutions. The test group will be 217 subjects (including approximately 20 subjects for the exploratory assessment of PK) and the control group will be 217 subjects (including approximately 20 subjects for the exploratory assessment of PK). Overall study period is approximately 24 months from the date of approval by the Institutional Review Boa…
Eligibility
- Age range
- 50+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Age ≥ 50 years at screening 2. Individuals with active CNV lesion secondary to AMD in the study eye, proven by fluorescein angiography (FA) and confirmed by the central reading center during the screening period 3. Individuals with CNV area in the study eye accounting for ≥ 50% of the total lesion, including macular hemorrhage, scar, atrophy, fibrosis and neovascularization, proven by FA and confirmed by the central reading center during the screening period 4. Individuals with intraretinal or subretinal fluid in the study eye due to active CNV, proven by optical cohere…
Interventions
- DrugRBS-001 Solution for intravitreal injection
Administer 2 mg/eye (50 uL/eye) per dose of the IP via IVT to the subjects' study eye
- DrugEylea® Solution for intravitreal injection
Administer 2 mg/eye (50 uL/eye) per dose of the IP via IVT to the subjects' study eye
Locations (7)
- Associated Retina Consultants - PhoenixPhoenix, Arizona
- Associated Retina Consultants - GilbertPhoenix, Arizona
- Retina Partners of Northwest Arkansas, PLLCSpringdale, Arkansas
- Erie Retina ResearchErie, Pennsylvania
- Charles Retina InstituteGermantown, Tennessee
- Retina Research Institute of TexasAbilene, Texas