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