NCT06961370TerminatedPhase 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)
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
Source: ClinicalTrials.gov · Last updated 4 Nov 2026
Reason given: The study was terminated prematurely by the Sponsor due to observation of dose-limiting adverse events meeting the protocol-defined stopping criteria.
Brief summary (registry, in English)
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.
- Status (registry)
- Terminated
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 27 (actual)
- First submitted
- 29 Apr 2025
- Start date
- 16 Jul 2025
- Primary completion date
- 3 Feb 2026
- Lead sponsor
- Hoffmann-La Roche
- Diseases
- Macular degeneration
- NCT number
- NCT06961370
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- 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
Other illness
- Active or history of CNV
- Ocular Exclusion Criteria for the Non-Study Eye:
Other
- Ocular Exclusion Criteria for the Study Eye:
- Aphakic or pseudophakic with intraocular lens outside of the capsular bag
- 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
Who the study is looking for
- 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
Age in the registry: 55 years to - · Sex: All · Does not accept healthy volunteers
Sites (17)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Southeast Retina Center | Augusta | United States | Unknown status |
| Austin Clinical Research, LLC | Austin | United States | Unknown status |
| Retina - Vitreous Associates Medical Group, PC | Beverly Hills | United States | Unknown status |
| Texas Retina Associates | Dallas | United States | Unknown status |
| Erie Retina Research | Erie | United States | Unknown status |
| Charles Retina Institute | Germantown | United States | Unknown status |
| Global Research Management | Glendale | United States | Unknown status |
| Cumberland Valley Retina Consultants PC | Hagerstown | United States | Unknown status |
| Tennessee Retina, PC | Nashville | United States | Unknown status |
| Associated Retina Consultants - Phoenix - DocTrials - PPDS | Phoenix | United States | Unknown status |
| Retina Northwest | Portland | United States | Unknown status |
| Retinal Consultants Medical Group Inc - Parkcenter Drive | Sacramento | United States | Unknown status |
| Retina Consultants of Texas Westover Hills Retina Center | San Antonio | United States | Unknown status |
| Deep Blue Retina Clinical Research | Southaven | United States | Unknown status |
| The Retina Institute | St Louis | United States | Unknown status |
| Barnet Dulaney Perkins Eye Center | Sun City | United States | Unknown status |
| Retina Consultants of Texas - The Woodlands | The Woodlands | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.