Safety and Tolerability Study of RO7171009 in Participants With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)

Study Overview
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Brief Summary
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This Phase 1, open-label, multicenter study will investigate the safety and tolerability of RO7171009 following single and multiple intravitreal (ITV) administrations in patients with GA secondary to AMD. The study consists of two stages: Single Dose-Escalation (SAD) and Multiple-Dose (MD) stages.

Official Title
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A Phase I, Multicenter, Open-Label, Single-Dose, Dose-Escalation, and Multiple-Dose Study of the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Intravitreal Injections of RO7171009 in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration

Conditions
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Geographic Atrophy

Intervention / Treatment
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* Drug: RO7171009


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants aged greater than or equal to (>/=) 50 years Well demarcated area(s) of GA secondary to AMD with no evidence of prior or active choroidal neovascularization (CNV) in study eye Exclusion Criteria: Ocular Exclusion Criteria, Study Eye: History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD Previous laser photocoagulation for CNV, diabetic macular edema, retinal vein occlusion, or proliferative diabetic retinopathy Prior treatment with Visudyne®, external beam radiation therapy (for intraocular conditions), or transpupillary thermotherapy Ocular Exclusion Criteria (Both Eyes): GA in either eye due to causes other than AMD Evidence of prior or active CNV Previous participation in interventional clinical trials for GA or dry AMD, except for vitamins and minerals, irrespective of the route of administration (i.e., ocular or systemic) within the last 6 months

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RO7171009: SAD<br>Patients will receive a single dose of RO7171009, in multiple escalating cohorts. | Drug: RO7171009<br>* Patients will receive RO7171009 via ITV injection.<br>|
| Experimental: RO7171009: MD<br>Patients will receive RO7171009 at maximum tolerated dose (MTD), identified during the SAD stage for three doses. | Drug: RO7171009<br>* Patients will receive RO7171009 via ITV injection.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Tolerability of the Study Drug: Rate of Adverse Events |  | Through study completion or early study discontinuation (overall 12-20 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum Concentration of RO7171009 |  | Through study completion or early study discontinuation (overall 12-20 weeks) |