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
Overview
- Phase
- Phase 3
- Intervention
- RBS-001 Solution for intravitreal injection
- Conditions
- Neovascular Age-related Macular Degeneration (nAMD)
- Sponsor
- Rophibio, Inc.
- Enrollment
- 434
- Locations
- 7
- Primary Endpoint
- Change in Best-Corrected Visual Acuity (BCVA) measured by Early treatment Diabetic Retinopathy Study (ETDRS) letter score at 8 weeks after the IP treatment
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief 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.
Detailed 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 Board (IRB) or the Independent Ethics Committee (IEC). Study period for individual subjects is approximately 56 weeks (up to 28 days of screening + 48 weeks of treatment + 4 weeks of follow-up).
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
- •Individuals with BCVA of 34 to 73 letters measured by ETDRS letter score at the screening and baseline visits in the study eye
- •Individuals who voluntarily decide to participate in the clinical study after being fully informed of the details of the clinical study and who provide written consent to comply with the study instructions during the clinical study
Exclusion Criteria
- •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
- •Retinal pigment epithelial tears or rips - Macular involvement
- •Macular hole - At any stage, if present in the study eye
- •Other causes of CNV - Ocular histoplasmosis syndrome, trauma, multifocal choroiditis, angioid streaks, history of choroidal rupture, pathologic myopia (spherical equivalent of negative 8 diopters or more or axial length of 25 mm or more), etc.
- •Individuals with any of the following concurrent diseases at screening or for a specified period of time
- •i. Concurrent ocular disease ii. Systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg (despite adequate treatment) iii. Uncontrolled diabetes mellitus, at the investigator's discretion iv. Congestive heart failure with New York Heart Association (NYHA) functional classification 3 or 4 or any clinically significant heart disease including ventricular arrhythmia and atrial fibrillation, at the investigator's discretion v. Active systemic infection undergoing treatment or recurrent clinically significant infections within 4 weeks prior to the first dose of the IP
- •Individuals with any medical history of the following at screening:
Arms & Interventions
RBS-001 treatment group
All eligible subjects according to the inclusion/exclusion criteria will be randomized into the RBS-001 treatment group or Eylea® treatment group in a ratio of 1:1 with the BCVA score
Intervention: RBS-001 Solution for intravitreal injection
Eylea® treatment group
All eligible subjects according to the inclusion/exclusion criteria will be randomized into the RBS-001 treatment group or Eylea® treatment group in a ratio of 1:1 with the BCVA score
Intervention: Eylea® Solution for intravitreal injection
Outcomes
Primary Outcomes
Change in Best-Corrected Visual Acuity (BCVA) measured by Early treatment Diabetic Retinopathy Study (ETDRS) letter score at 8 weeks after the IP treatment
Time Frame: The change from baseline (Day 1) to 8 weeks after the IP treatment
Secondary Outcomes
- Change in Best-Corrected Visual Acuity (BCVA) measured by Early treatment Diabetic Retinopathy Study (ETDRS) letter score at 4, 8, 12, 16, 20, and 24 weeks after the IP treatment(The change from baseline (Day 1) to 4, 8, 12, 16, 20, and 24 weeks after the IP treatment)