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AzTrials

Geographic AtrophyPhase 1NCT06961370

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 1 study testing RO7669330, Syfovre™ and Izervay™ in people with Geographic Atrophy and Age-related Macular Degeneration, run by Hoffmann-La Roche at 17 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 55 years and older
What is being tested?
RO7669330, Syfovre™ and Izervay™
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
17 sitesUnited States
Study dates
16 Jul 2025to 3 Mar 2026
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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 cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

United States17 sites

  • Southeast Retina Center

    Augusta, Georgia, 30909

  • Austin Clinical Research, LLC

    Austin, Texas, 78750

  • Retina - Vitreous Associates Medical Group, PC

    Beverly Hills, California, 90211-1838

  • Texas Retina Associates

    Dallas, Texas, 75231

  • Erie Retina Research

    Erie, Pennsylvania, 16505

  • Charles Retina Institute

    Germantown, Tennessee, 38138

  • Global Research Management

    Glendale, California, 91204

  • Cumberland Valley Retina Consultants PC

    Hagerstown, Maryland, 21740

  • Tennessee Retina PC

    Nashville, Tennessee, 37203

  • Associated Retina Consultants - Phoenix - DocTrials - PPDS

    Phoenix, Arizona, 85020-5505

  • Retina Northwest

    Portland, Oregon, 97221

  • Retinal Consultants Medical Group Inc - Parkcenter Drive

    Sacramento, California, 95825

  • Retina Consultants of Texas Westover Hills Retina Center

    San Antonio, Texas, 78251

  • Deep Blue Retina Clinical Research

    Southaven, Mississippi, 38671

  • The Retina Institute

    St Louis, Missouri, 63128

  • Barnet Dulaney Perkins Eye Center

    Sun City, Arizona, 85351

  • Retina Consultants of Texas - (The Woodlands)

    The Woodlands, Texas, 77384

Other trials in United States

About this study

Official title: 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

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.

Being tested
RO7669330, Syfovre™, Izervay™
Medical subject headings
Geographic Atrophy, Macular Degeneration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RO7669330Drug

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

  • Syfovre™Drug

    Also called Pegcetacoplan injection

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

  • Izervay™Drug

    Also called Avacincaptad pegol IVT solution

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

Study groups in NCT06961370
Study groupRoleWhat they receive
Part 1A: Multiple Ascending Dose (MAD)ExperimentalParticipants will receive multiple doses of RO7669330 as IVT injections in the study eye with additional cohorts of participants receiving higher doses of RO7669330.
Receives: Drug: RO7669330
Part 1B: Syfovre and IzervayExperimentalParticipants will receive either Syfovre, 15 milligrams (mg) or Izervay, 2 mg, as an IVT injection in the study eye.
Receives: Drug: Syfovre™; Drug: Izervay™
Part 2: RO7669330 vs Active Comparator (Syfovre or Izervay)ExperimentalParticipants will receive RO7669330 (at two dose levels) or the active comparator (either Syfovre or Izervay), as an IVT injection in the study eye.
Receives: Drug: RO7669330; Drug: Syfovre™; Drug: Izervay™

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Adverse Events (AEs)

    Measured: Up to a maximum of 34 weeks

  2. Number of Participants With Abnormalities Recorded in Standard Ophthalmological Assessments

    The standard ophthalmological assessments that will be conducted may include the following: slit-lamp, indirect ophthalmology, intraocular pressure (IOP), best corrected visual acuity (BCVA), spectral domain optical coherence tomography (SD-OCT), fundus fluorescein angiography (FFA), and color fundus photography (CFP).

    Measured: Up to a maximum of 34 weeks

Secondary outcomes (1)

  1. Part 1A and Part 2: Ocular and Systemic Concentration of RO7669330

    Measured: Up to a maximum of Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 May 2025
  2. Study start16 Jul 2025
  3. Primary completion3 Feb 2026
  4. Study completion3 Mar 2026

Why it stopped: The study was terminated prematurely by the Sponsor due to observation of dose-limiting adverse events meeting the protocol-defined stopping criteria.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Part 1A will be a single group study, while Part 1B and Part 2 will follow a parallel-group design.
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06961370
Sponsor's protocol ID
BP45482
Status last verified
Nov 2026
First submitted
29 Apr 2025
Last updated
4 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing RO7669330, Syfovre™ and Izervay™ in people with Geographic Atrophy and Age-related Macular Degeneration, run by Hoffmann-La Roche at 17 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: The study was terminated prematurely by the Sponsor due to observation of dose-limiting adverse events meeting the protocol-defined stopping criteria.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Adverse Events (AEs) (time frame: Up to a maximum of 34 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06961370.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.

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