Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 1INTERVENTIONAL

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

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) (NCT06961370) is a Phase 1 interventional studying Geographic Atrophy and Age-related Macular Degeneration, sponsored by Hoffmann-La Roche. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Geographic Atrophy, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 132 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Geographic Atrophy subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: 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 Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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 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

Treatments Being Tested

DRUG

RO7669330

RO7669330 will be administered as an IVT injection in the study eye per the schedule specified in the respective arms.

DRUG

Syfovre™

Syfovre™ will be administered as an IVT injection in the study eye per the schedule specified in the respective arms.

DRUG

Izervay™

Izervay™ will be administered as an IVT injection in the study eye per the schedule specified in the respective arms.

Locations (16)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

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

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06961370), the sponsor (Hoffmann-La Roche), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06961370 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06961370?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06961370?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06961370. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06961370. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.