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RECRUITING
NCT06961370
PHASE1

A Study to Investigate Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD), and Immunogenicity of RO7669330 in Participants With Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD)

Sponsor: Hoffmann-La Roche

View on ClinicalTrials.gov

Summary

The main purpose of this study is to assess the ocular and systemic safety and tolerability of RO7669330 in participants with GA secondary to AMD in at least one eye in Part 1, or both eyes in Part 2, after multiple unilateral intravitreal (IVT) doses.

Official title: A Phase I, Multi-center, Multi-part Study to Investigate Safety, Tolerability, PK, PD, and Immunogenicity of RO7669330 Intravitreal Injections in Participants With GA Secondary to AMD: Part 1A: Open-label, MAD; Part 1B: Randomized PD Pilot; Part 2: Masked, Randomized, Active-comparator-controlled

Key Details

Gender

All

Age Range

55 Years - Any

Study Type

INTERVENTIONAL

Enrollment

132

Start Date

2025-07-16

Completion Date

2027-01-03

Last Updated

2026-04-03

Healthy Volunteers

No

Interventions

DRUG

RO7669330

RO7669330 will be administered as an IVT injection in the study eye per the schedule specified in the respective arms.

DRUG

Syfovre™

Syfovre™ will be administered as an IVT injection in the study eye per the schedule specified in the respective arms.

DRUG

Izervay™

Izervay™ will be administered as an IVT injection in the study eye per the schedule specified in the respective arms.

Locations (16)

Associated Retina Consultants - Phoenix - DocTrials - PPDS

Phoenix, Arizona, United States

Barnet Dulaney Perkins Eye Center

Sun City, Arizona, United States

Retina-Vitreous Associates Medical Group

Beverly Hills, California, United States

Global Research Management

Glendale, California, United States

Retinal Consultants Medical Group Inc - Parkcenter Drive

Sacramento, California, United States

Southeast Retina Center

Augusta, Georgia, United States

Cumberland Valley Retina Consultants PC

Hagerstown, Maryland, United States

The Retina Institute

St Louis, Missouri, United States

Retina Northwest

Portland, Oregon, United States

Erie Retina Research

Erie, Pennsylvania, United States

Charles Retina Institute

Germantown, Tennessee, United States

Tennessee Retina PC

Nashville, Tennessee, United States

Austin Clinical Research, LLC

Austin, Texas, United States

Texas Retina Associates

Dallas, Texas, United States

Retina Consultants of Texas Westover Hills Retina Center

San Antonio, Texas, United States

Retina Consultants of Texas - (The Woodlands)

The Woodlands, Texas, United States