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NOT YET RECRUITING
NCT06470373
PHASE3

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

Sponsor: Rophibio, Inc.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

50 Years - Any

Study Type

INTERVENTIONAL

Enrollment

434

Start Date

2025-07

Completion Date

2026-09

Last Updated

2025-04-06

Healthy Volunteers

No

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

Locations (7)

Associated Retina Consultants - Phoenix

Phoenix, Arizona, United States

Associated Retina Consultants - Gilbert

Phoenix, Arizona, United States

Retina Partners of Northwest Arkansas, PLLC

Springdale, Arkansas, United States

Erie Retina Research

Erie, Pennsylvania, United States

Charles Retina Institute

Germantown, Tennessee, United States

Retina Research Institute of Texas

Abilene, Texas, United States

Strategic Clinical Research Group, LLC

Willow Park, Texas, United States