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

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06961370

Enrollment

Registered

2025-05-07

Start date

2025-07-16

Completion date

2026-03-03

Last updated

2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Age-related Macular Degeneration, Geographic Atrophy

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.

Interventions

DRUGRO7669330

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

DRUGSyfovre™

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

DRUGIzervay™

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Masking description

Part 1A of the study will be open-label and non-randomized while Part 1B and 2 will be masked and randomized.

Intervention model description

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

Eligibility

Sex/Gender

ALL

Age

55 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants With Adverse Events (AEs)	Up to a maximum of 34 weeks	—
Number of Participants With Abnormalities Recorded in Standard Ophthalmological Assessments	Up to a maximum of 34 weeks	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).

Secondary

Measure	Time frame
Part 1A and Part 2: Ocular and Systemic Concentration of RO7669330	Up to a maximum of Week 24

Countries

United States

Contacts

STUDY_DIRECTORClinical Trials

Hoffmann-La Roche

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 11, 2026