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
Hoffmann-La Roche
132 participants
Jul 16, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria10
- 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 Criteria7
- 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 proliferative diabetic retinopathy
- Active or history of CNV
- \- Non-functioning non-study eye, defined as either: BCVA of hand motion or worse and/or no physical presence of eye
- Macular atrophy in either eye due to causes other than AMD
- Part 2: Evidence of prior or active CNV
- Prior treatment with any approved therapy for GA (Syfovre, Izervay) in either eye for Part 1A and Part 2 ≤ 20 weeks prior to Day 1. For Part 1B, prior treatment with any approved therapy for GA (Syfovre, Izervay) in the study eye ≤ 20 weeks prior to Day 1
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Interventions
RO7669330 will be administered as an IVT injection in the study eye per the schedule specified in the respective arms.
Syfovre™ will be administered as an IVT injection in the study eye per the schedule specified in the respective arms.
Izervay™ will be administered as an IVT injection in the study eye per the schedule specified in the respective arms.
Locations(16)
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NCT06961370