A Phase 3 Clinical Trial to Compare RBS-001 to Eylea® in Subjects With Neovascular Age-Related Macular Degeneration
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age50+
SponsorRophibio, Inc.
About this trial
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.
Eligibility criteria
Qualifiers
Age ≥ 50 years at screening
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
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
Individuals with intraretinal or subretinal fluid in the study eye due to active CNV, proven by optical coherence tomography (OCT) and confirmed by the central reading center during the screening period
Disqualifiers
Individuals whose study eye lesion meets any of the following criteria
Total lesion* size - > 23 mm2 [9 disc areas (DAs)] (Must be proven by FA)
Subretinal hemorrhage (or subfoveal hemorrhage) - ≥ 50% of the total lesion* [≥ 1 DA (In the case of subfoveal hemorrhage, fovea must be surrounded 270 degrees by visible CNV.)]
Scar or fibrosis - ≥ 50% of the total lesion* or Scar, fibrosis, or atrophy involving the center of the fovea
Trial design
Treatments tested in this trial
- RBS-001 Solution for intravitreal injection
- Eylea® Solution for intravitreal injection
Treatment groups
434 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov