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)
Stopped early · Phase 1
Conditions studied: Geographic Atrophy, Age-related Macular Degeneration
In brief
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.
Key facts
- Study ID
- NCT06961370
- Run by
- Hoffmann-La Roche
- People needed
- 27
- Starts
- 2025-07-16
- Expected to finish
- 2026-03-03
- Last updated by the study team
- 2026-08-10
Who can join
Age: 55 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Associated Retina Consultants - Phoenix - DocTrials - PPDS — Phoenix, Arizona, United States
- Barnet Dulaney Perkins Eye Center — Sun City, Arizona, United States
- Retina-Vitreous Associates Medical Group — Beverly Hills, California, United States
- Global Research Management — Glendale, California, United States
- Retinal Consultants Medical Group Inc - Parkcenter Drive — Sacramento, California, United States
- Southeast Retina Center — Augusta, Georgia, United States
- Cumberland Valley Retina Consultants PC — Hagerstown, Maryland, United States
- Deep Blue Retina Clinical Research — Southaven, Mississippi, United States
- The Retina Institute — St Louis, Missouri, United States
- Retina Northwest — Portland, Oregon, United States
- Erie Retina Research — Erie, Pennsylvania, United States
- Charles Retina Institute — Germantown, Tennessee, United States
- Tennessee Retina PC — Nashville, Tennessee, United States
- Austin Clinical Research, LLC — Austin, Texas, United States
- Texas Retina Associates — Dallas, Texas, United States
- Retina Consultants of Texas Westover Hills Retina Center — San Antonio, Texas, United States
- Retina Consultants of Texas - (The Woodlands) — The Woodlands, Texas, United States
Full record on ClinicalTrials.gov
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