A Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Intravitreal Injections of RO7303359 in Participants With Geographic Atrophy Secondary to Age-related Macular Degeneration

Study Overview
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Brief Summary
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This multicenter study will investigate the safety, tolerability, pharmacokinetics, and immunogenicity of RO7303359 following single intravitreal (ITV) injection in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). Participants will receive an ITV injection of RO7303359 in the single ascending dose stage and the maximum tolerated dose (MTD) or maximum tested dose (MTeD) of RO7303359 in the expansion stage.

Official Title
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A Phase 1a, Multicenter, Open-label, Single-dose, Dose-escalation Study of the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Intravitreal Injections of RO7303359 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: RO7303359


Participation Criteria
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Eligibility Criteria
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Ocular Inclusion Criteria Study Eye: Visual acuity: BCVA letter score of 19-48 ETDRS letters (Snellen equivalent of 20/125-20/400) using ETDRS charts at a starting distance of 4 meters Well-demarcated area of GA secondary to AMD in the absence of choroidal neovascularization (CNV) GA area must be >/= 0.5 disc area (1.25 mm^2) Ocular Exclusion Criteria, Study Eye: GA in the study eye due to causes other than AMD 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 photodynamic therapy, external beam radiation therapy (for intraocular conditions), or transpupillary thermotherapy Ocular Exclusion Criteria, Both eyes: 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: Single Ascending Dose Stage<br>Participants will receive a single dose of RO7303359, in multiple escalating cohorts (A-D). | Drug: RO7303359<br>* RO730359 will be administered as a single intravitreal injection.<br>|
| Experimental: Expansion Cohort Stage<br>Participants will receive the maximum tolerated dose (MTD) or the maximum tested dose (MTeD) as determined in the single ascending dose stage. | Drug: RO7303359<br>* RO730359 will be administered as a single intravitreal injection.<br>|
| Experimental: Optional Cohort E<br>An optional additional cohort may be added with the dose not exceed the MTD or MTeD. | Drug: RO7303359<br>* RO730359 will be administered as a single intravitreal injection.<br>|
| Experimental: Optional cohort F<br>An optional additional cohort may be added with the dose not exceed the MTD or MTeD. | Drug: RO7303359<br>* RO730359 will be administered as a single intravitreal injection.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Ocular Adverse Events |  | Up to 12 weeks | 
| Percentage of Participants With Systemic Adverse Events |  | Up to 12 weeks | 
| Percentage of Participants With Dose-limiting Adverse Events (DLAEs), |  | Up to 12 weeks | 
| Percentage of Participants With Serious Adverse Events (SAEs) |  | Up to 12 weeks | 
| Percentage of Participants With Adverse Events Leading to Study Discontinuation |  | Up to 12 weeks | 
| Percentage of Participants With Adverse Events of Special Interest (AESIs) |  | Up to 12 weeks | 
| Change from Baseline in Best Corrected Visual Acuity (BCVA) Score as Assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) Chart |  | Baseline, Week 12 |