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 range
55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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