A Study to Investigate Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD), and Im… (NCT06961370) | Clinical Trial Compass
Active — Not RecruitingPhase 1
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)
United States27 participantsStarted 2025-07-16
Plain-language 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.
Who can participate
Age range55 Years
SexALL
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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 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…
What they're measuring
1
Number of Participants With Adverse Events (AEs)
Timeframe: Up to a maximum of 34 weeks
2
Number of Participants With Abnormalities Recorded in Standard Ophthalmological Assessments