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)
NCT ID: NCT06961370
Last Updated: 2026-01-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE1
132 participants
INTERVENTIONAL
2025-07-16
2027-01-03
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Intravitreal Injections of RO7303359 in Participants With Geographic Atrophy Secondary to Age-related Macular Degeneration
NCT04615325
Safety and Tolerability Study of RO7171009 in Participants With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)
NCT03295877
Study to Assess the Adverse Events and How Intravitreal ABBV-6628 Moves Through the Body of Adult Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration
NCT07160179
A Safety and Efficacy Study of a One-time Intravitreal Injection of SAR446597 in Participants With Geographic Atrophy Secondary to Age-related Macular Degeneration
NCT07215234
A Phase 1, Safety, Tolerability and Pharmacokinetic Profile of Intravitreous Injections of E10030 (Anti-PDGF Pegylated Aptamer) in Subjects With Neovascular Age-Related Macular Degeneration
NCT00569140
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Part 1B: Syfovre and Izervay
Participants will receive either Syfovre, 15 milligrams (mg) or Izervay, 2 mg, as an IVT injection in the study eye.
Syfovre™
Syfovre™ will be administered as an IVT injection in the study eye per the schedule specified in the respective arms.
Izervay™
Izervay™ will be administered as an IVT injection in the study eye per the schedule specified in the respective arms.
Part 2: RO7669330 vs Active Comparator (Syfovre or Izervay)
Participants will receive RO7669330 (at two dose levels) or the active comparator (either Syfovre or Izervay), as an IVT injection in the study eye.
RO7669330
RO7669330 will be administered as an IVT injection in the study eye per the schedule specified in the respective arms.
Syfovre™
Syfovre™ will be administered as an IVT injection in the study eye per the schedule specified in the respective arms.
Izervay™
Izervay™ will be administered as an IVT injection in the study eye per the schedule specified in the respective arms.
Part 1A: Multiple Ascending Dose (MAD)
Participants will receive multiple doses of RO7669330 as IVT injections in the study eye with additional cohorts of participants receiving higher doses of RO7669330.
RO7669330
RO7669330 will be administered as an IVT injection in the study eye per the schedule specified in the respective arms.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
RO7669330
RO7669330 will be administered as an IVT injection in the study eye per the schedule specified in the respective arms.
Syfovre™
Syfovre™ will be administered as an IVT injection in the study eye per the schedule specified in the respective arms.
Izervay™
Izervay™ will be administered as an IVT injection in the study eye per the schedule specified in the respective arms.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
\- Non-functioning non-study eye, defined as either: BCVA of hand motion or worse and/or no physical presence of eye
* 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
55 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hoffmann-La Roche
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
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
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Reference Study ID Number: BP45482 https://forpatients.roche.com/
Role: CONTACT
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
BP45482
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.