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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04615325

Enrollment

Registered

2020-11-04

Start date

2020-12-08

Completion date

2023-01-04

Last updated

2023-03-01

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

Conditions

Geographic Atrophy

Brief summary

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.

Interventions

DRUGRO7303359

RO730359 will be administered as a single intravitreal injection.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026