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)

Phase 1

Recruiting

• Conditions: Geographic Atrophy; Age-related Macular Degeneration
• Interventions: Drug: RO7669330; Drug: Syfovre™; Drug: Izervay™

• Registration Number: NCT06961370
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

The main purpose of this study is to assess the ocular and systemic safety and tolerability of RO7669330 in GA secondary to AMD after multiple unilateral intravitreal (IVT) doses.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-04-29
• Study First Submitted QC: 2025-04-29
• Status Verified: 2025-05
• Study First Posted: 2025-05-07
• Last Update Submitted: 2025-05-19
• Last Update Posted: 2025-05-20
• Study Start: 2025-05-21
• Primary Completion: 2027-01-03
• Study Completion: 2027-01-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 132

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 ≤ 17.5 mm^2 )
• Part 2: ≥ 2.5 mm^2 and ≤ 17.5 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

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
• 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. For Part 1B, prior treatment with any approved therapy for GA (Syfovre, Izervay) in the study eye ≤ 20 weeks prior to Day 1

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Part 1A: Multiple Ascending Dose (MAD)	RO7669330	Participants will receive multiple doses of RO7669330 as IVT injections in the study eye with additional cohorts of participants receiving higher doses of RO7669330.
Part 1B: Syfovre and Izervay	Syfovre™	Participants will receive either Syfovre 15 milligrams (mg) or Izervay 2 mg, as an IVT injection in the study eye.
Part 1B: Syfovre and Izervay	Izervay™	Participants will receive either Syfovre 15 milligrams (mg) or Izervay 2 mg, as an IVT injection in the study eye.
Part 2: RO7669330 vs Active Comparator (Syfovre or Izervay)	RO7669330	Participants will receive RO7669330 (at two dose levels) or the active comparator (either Syfovre or Izervay), as an IVT injection in the study eye.
Part 2: RO7669330 vs Active Comparator (Syfovre or Izervay)	Syfovre™	Participants will receive RO7669330 (at two dose levels) or the active comparator (either Syfovre or Izervay), as an IVT injection in the study eye.
Part 2: RO7669330 vs Active Comparator (Syfovre or Izervay)	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Abnormalities Recorded in Standard Ophthalmological Assessments	Up to a maximum of 32 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).
Number of Participants With Adverse Events (AEs)	Up to a maximum of 32 weeks

Secondary Outcome Measures

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

Trial Locations

Locations (5)

Global Research Management; 🇺🇸 Glendale, California, United States

Southeast Retina Center; 🇺🇸 Augusta, Georgia, United States

Erie Retina Research; 🇺🇸 Erie, Pennsylvania, United States

Charles Retina Institute; 🇺🇸 Germantown, Tennessee, United States

Texas Retina Associates; 🇺🇸 Dallas, Texas, United States