NCT06470373

A Phase 3 Clinical Trial to Compare RBS-001 to Eylea® in Subjects With Neovascular Age-Related Macular Degeneration

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

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 434 (estimated)
• Sponsor: Rophibio, Inc. · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Neovascular Age-related Macular Degeneration (nAMD)

Interventions

Type	Name	Description
DRUG	RBS-001 Solution for intravitreal injection	Administer 2 mg/eye (50 uL/eye) per dose of the IP via IVT to the subjects' study eye
DRUG	Eylea® Solution for intravitreal injection	Administer 2 mg/eye (50 uL/eye) per dose of the IP via IVT to the subjects' study eye

Timeline

• Start date: 2025-07-01
• Primary completion: 2026-09-01
• Completion: 2026-09-01
• First posted: 2024-06-24
• Last updated: 2025-04-06

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study