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 | Recruiting Phase 1 FDA Drug

• 1 other identifier: BP45482
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 16

Brief 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.

Conditions

Age-related Macular Degeneration; Geographic Atrophy

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Adverse Events (AEs)

  Up to a maximum of 34 weeks

• 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).

  Up to a maximum of 34 weeks

Secondary Outcomes (1)

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

  Up to a maximum of Week 24

Study Arms (3)

Part 1A: Multiple Ascending Dose (MAD)

EXPERIMENTAL

Participants will receive multiple doses of RO7669330 as IVT injections in the study eye with additional cohorts of participants receiving higher doses of RO7669330.

Drug: RO7669330

Part 1B: Syfovre and Izervay

EXPERIMENTAL

Participants will receive either Syfovre, 15 milligrams (mg) or Izervay, 2 mg, as an IVT injection in the study eye.

Drug: Syfovre™; Drug: Izervay™

Part 2: RO7669330 vs Active Comparator (Syfovre or Izervay)

EXPERIMENTAL

Participants will receive RO7669330 (at two dose levels) or the active comparator (either Syfovre or Izervay), as an IVT injection in the study eye.

Drug: RO7669330; Drug: Syfovre™; Drug: Izervay™

Interventions

RO7669330 DRUG

RO7669330 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); Part 2: RO7669330 vs Active Comparator (Syfovre or Izervay)

Syfovre™ DRUG

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

Also known as: Pegcetacoplan injection

Part 1B: Syfovre and Izervay; Part 2: RO7669330 vs Active Comparator (Syfovre or Izervay)

Izervay™ DRUG

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

Also known as: Avacincaptad pegol IVT solution

Part 1B: Syfovre and Izervay; Part 2: RO7669330 vs Active Comparator (Syfovre or Izervay)

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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:

• 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
• \- 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (16)

Associated Retina Consultants - Phoenix - DocTrials - PPDS

Phoenix, Arizona, 85020-5505, United States

RECRUITING

Barnet Dulaney Perkins Eye Center

Sun City, Arizona, 85351, United States

RECRUITING

Retina-Vitreous Associates Medical Group

Beverly Hills, California, 90211, United States

RECRUITING

Global Research Management

Glendale, California, 91204, United States

RECRUITING

Retinal Consultants Medical Group Inc - Parkcenter Drive

Sacramento, California, 95825, United States

RECRUITING

Southeast Retina Center

Augusta, Georgia, 30909, United States

RECRUITING

Cumberland Valley Retina Consultants PC

Hagerstown, Maryland, 21740, United States

RECRUITING

The Retina Institute

St Louis, Missouri, 63128, United States

RECRUITING

Retina Northwest

Portland, Oregon, 97221, United States

RECRUITING

Erie Retina Research

Erie, Pennsylvania, 16505, United States

RECRUITING

Charles Retina Institute

Germantown, Tennessee, 38138, United States

RECRUITING

Tennessee Retina PC

Nashville, Tennessee, 37203, United States

RECRUITING

Austin Clinical Research, LLC

Austin, Texas, 78750, United States

RECRUITING

Texas Retina Associates

Dallas, Texas, 75231, United States

RECRUITING

Retina Consultants of Texas Westover Hills Retina Center

San Antonio, Texas, 78251, United States

RECRUITING

Retina Consultants of Texas - (The Woodlands)

The Woodlands, Texas, 77384, United States

RECRUITING

MeSH Terms

Conditions

Geographic Atrophy; Macular Degeneration

Interventions

pegcetacoplan

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Central Study Contacts

Reference Study ID Number: BP45482 https://forpatients.roche.com/

CONTACT

888-662-6728 (U.S. Only); global-roche-genentech-trials@gene.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Part 1A of the study will be open-label and non-randomized while Part 1B and 2 will be masked and randomized.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Part 1A will be a single group study, while Part 1B and Part 2 will follow a parallel-group design.

Study Record Dates

• First Submitted: April 29, 2025
• First Posted: May 7, 2025
• Study Start: July 16, 2025
• Primary Completion (Estimated): January 3, 2027
• Study Completion (Estimated): January 3, 2027
• Last Updated: May 4, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (16)