Status:
RECRUITING
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)
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Geographic Atrophy
Age-related Macular Degeneration
Eligibility:
All Genders
55+ years
Phase:
PHASE1
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,...
Eligibility Criteria
Inclusion
- 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
- 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 proliferative diabetic retinopathy
- Active or history of CNV
- Ocular Exclusion Criteria for the Non-Study Eye:
- \- Non-functioning non-study eye, defined as either: BCVA of hand motion or worse and/or no physical presence of eye
- Ocular Exclusion Criteria for Both Eyes:
- 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
Key Trial Info
Start Date :
July 16 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 3 2027
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT06961370
Start Date
July 16 2025
End Date
January 3 2027
Last Update
January 9 2026
Active Locations (16)
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1
Associated Retina Consultants - Phoenix - DocTrials - PPDS
Phoenix, Arizona, United States, 85020-5505
2
Barnet Dulaney Perkins Eye Center
Sun City, Arizona, United States, 85351
3
Retina-Vitreous Associates Medical Group
Beverly Hills, California, United States, 90211
4
Global Research Management
Glendale, California, United States, 91204