NCT06961370

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)

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 132 (estimated)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Geographic Atrophy
• Age-related Macular Degeneration

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-07-16
• Primary completion: 2027-01-03
• Completion: 2027-01-03
• First posted: 2025-05-07
• Last updated: 2026-04-03

Locations

16 sites across 1 country: United States

Regulatory

• FDA-regulated drug study