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

NCT06470373 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 434

Last updated 2025-04-06

No results posted yet for this study

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.

Conditions

  • Neovascular Age-related Macular Degeneration (nAMD)

Interventions

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

Sponsors & Collaborators

  • Rophibio, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-31
Primary Completion
2026-09-30
Completion
2026-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06470373 on ClinicalTrials.gov