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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04615325
Other study ID # GR42163
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date December 8, 2020
Est. completion date January 4, 2023

Study information

Verified date February 2023
Source Hoffmann-La Roche
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 37
Est. completion date January 4, 2023
Est. primary completion date January 4, 2023
Accepts healthy volunteers No
Gender All
Age group 50 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
RO7303359
RO730359 will be administered as a single intravitreal injection.

Locations

Country Name City State
United States Western Carolina Retinal Associate PA Asheville North Carolina
United States Austin Clinical Research LLC Austin Texas
United States Retina Foundation of the Southwest Dallas Texas
United States Colorado Retina Associates, PC Denver Colorado
United States Florida Eye Associates Melbourne Florida
United States Northern California Retina Vitreous Associates Mountain View California
United States Tennessee Retina PC. Nashville Tennessee
United States University Retina and Macula Associates, PC Oak Forest Illinois
United States Sierra Eye Associates Reno Nevada
United States Associated Retinal Consultants PC Royal Oak Michigan
United States Retinal Consultants Med Group Sacramento California
United States California Retina Consultants - Santa Maria Santa Maria California

Sponsors (1)

Lead Sponsor Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

United States, 

Outcome

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