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Recruiting Phase 1 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)

Trial Parameters

Condition Geographic Atrophy
Sponsor Hoffmann-La Roche
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 132
Sex ALL
Min Age 55 Years
Max Age N/A
Start Date 2025-07-16
Completion 2027-01-03
Interventions
RO7669330Syfovre™Izervay™

Brief 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.

Eligibility Criteria

Inclusion Criteria: * Adequately clear ocular media, adequate pupillary dilation, and fixation to allow acquisition of good quality fundus imaging * GA that resides completely within the fundus autofluorescence (FAF) imaging field * Presence of hyperautofluorescence of either banded or diffuse pattern adjacent to the GA area on FAF * Study eye has early treatment of diabetic retinopathy study (ETDRS) best-corrected visual acuity (BCVA) score as follows: * Part 1A: 19 to 48 letters, inclusively * Part 1B: \> 19 letters * Part 2: ≥ 24 letters * Total GA lesion size must be as follows: * Parts 1A and 1B: ≥ 1.25 square millimeter (mm\^2) and ≤ 20 mm\^2 ) * Part 2: ≥ 2.5 mm\^2 and ≤ 20 mm\^2 Exclusion Criteria: Ocular Exclusion Criteria for the Study Eye: * Aphakic or pseudophakic with intraocular lens outside of the capsular bag * Previous laser photocoagulation or IVT anti-vascular endothelial growth factor (VEGF) for CNV, diabetic macular edema (DME), retinal vein occlusion (RVO), or pro

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