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

Phase 1

Completed

• Conditions: Geographic Atrophy
• Interventions: Drug: RO7303359

• Registration Number: NCT04615325
• Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-29
• Study First Submitted QC: 2020-10-29
• Study First Posted: 2020-11-04
• Study Start: 2020-12-08
• Primary Completion: 2023-01-04
• Study Completion: 2023-01-04
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-27
• Last Update Posted: 2023-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Expansion Cohort Stage	RO7303359	Participants will receive the maximum tolerated dose (MTD) or the maximum tested dose (MTeD) as determined in the single ascending dose stage.
Optional cohort F	RO7303359	An optional additional cohort may be added with the dose not exceed the MTD or MTeD.
Optional Cohort E	RO7303359	An optional additional cohort may be added with the dose not exceed the MTD or MTeD.
Single Ascending Dose Stage	RO7303359	Participants will receive a single dose of RO7303359, in multiple escalating cohorts (A-D).

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Ocular Adverse Events	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
Percentage of Participants With Serious Adverse Events (SAEs)	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
Percentage of Participants With Systemic Adverse Events	Up to 12 weeks
Percentage of Participants With Dose-limiting Adverse Events (DLAEs),	Up to 12 weeks

Trial Locations

Locations (12)

California Retina Consultants - Santa Maria; 🇺🇸 Santa Maria, California, United States

University Retina and Macula Associates, PC; 🇺🇸 Oak Forest, Illinois, United States

Austin Clinical Research LLC; 🇺🇸 Austin, Texas, United States

Northern California Retina Vitreous Associates; 🇺🇸 Mountain View, California, United States

Florida Eye Associates; 🇺🇸 Melbourne, Florida, United States

Associated Retinal Consultants PC; 🇺🇸 Royal Oak, Michigan, United States

Western Carolina Retinal Associate PA; 🇺🇸 Asheville, North Carolina, United States

Retina Foundation of the Southwest; 🇺🇸 Dallas, Texas, United States

Sierra Eye Associates; 🇺🇸 Reno, Nevada, United States

Retinal Consultants Med Group; 🇺🇸 Sacramento, California, United States

Colorado Retina Associates, PC; 🇺🇸 Denver, Colorado, United States

Tennessee Retina PC.; 🇺🇸 Nashville, Tennessee, United States