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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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

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.

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)

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