A Study of NGM621 in Participants With Geographic Atrophy

Geographic Atrophy Clinical Trial

— CATALINA  

Official title:

A Phase 2 Multicenter, Randomized, Double-Masked, Sham-Controlled Study of the Safety and Efficacy of Intravitreal Injections of NGM621 in Subjects With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04465955
• Other study ID #: 621-GA-201
• Status: Completed
• Phase: Phase 2
• Start date: July 22, 2020
• Est. completion date: August 16, 2022

Study information

• Verified date: June 2023
• Source: NGM Biopharmaceuticals, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a multi-center evaluation of NGM621 in a randomized, double-masked, sham-controlled study in participants with Geographic Atrophy secondary to Age-related Macular Degeneration.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 320
• Est. completion date: August 16, 2022
• Est. primary completion date: August 16, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

Inclusion Criteria:

• Male or female (non-pregnant, non-lactating) subjects = 55 years

• Standard luminance BCVA score of 34 letters or better using ETDRS charts at the starting distance of 4 meters (approximately 20/200 Snellen equivalent or better) in study eye

• Clinical diagnosis of GA secondary to AMD:

1. Total GA area must be = 2.5 and = 17.5 mm²

2. If GA is multifocal, at least one focal lesion must be = 1.25 mm² (0.5 DA), with the overall area of GA = 2.5 and = 17.5 mm²

3. Well demarcated GA with no anatomical evidence of current or prior CNV in the study eye

Exclusion Criteria:

Study Eye

• GA secondary to a condition other than AMD in either eye (e.g., monogenetic macular dystrophies like Stargardt disease, cone rod dystrophy, or toxic maculopathies)

• Any history of or active choroidal neovascularization (CNV)

Both Eyes

• Any history of or active bacterial, viral, fungal, or parasitic infection in either eye in the 3 months prior to randomization

Related Conditions & MeSH terms

• Atrophy
• Geographic Atrophy

Intervention

Biological:
• NGM621
NGM621 Dose 1
• NGM621
NGM621 Dose 2

Other:
• Sham Comparator
Sham Comparator

Locations

Country	Name	City	State
United States	Texas Retina Associates	Arlington	Texas
United States	Western Carolina Retinal Associates	Asheville	North Carolina
United States	California Retina Consultants	Bakersfield	California
United States	Elman Retina Group PA	Baltimore	Maryland
United States	Thompson Sjaarda, PA	Baltimore	Maryland
United States	Retina Vitreous Associates	Beverly Hills	California
United States	Gailey Eye Clinic - Bloomington	Bloomington	Illinois
United States	Ophthalmic Consultants of Boston	Boston	Massachusetts
United States	Florida Eye Microsurgical Institute	Boynton Beach	Florida
United States	Retinal Diagnostic Center	Campbell	California
United States	Southeast Clinical Research	Charlotte	North Carolina
United States	University of Virginia	Charlottesville	Virginia
United States	University of Illinois	Chicago	Illinois
United States	Sterling Research Group, Ltd.	Cincinnati	Ohio
United States	Retina Associates of Cleveland	Cleveland	Ohio
United States	The Cleveland Clinic	Cleveland	Ohio
United States	Retina Consultants of Southern Colorado PC	Colorado Springs	Colorado
United States	University of Miami	Coral Gables	Florida
United States	Specialty Retina Center (Coral Springs)	Coral Springs	Florida
United States	Retina Foundation of the Southwest	Dallas	Texas
United States	Texas Retina Associates-Plano	Dallas	Texas
United States	Duke University	Durham	North Carolina
United States	The Retina Partners	Encino	California
United States	Retina Group of Florida	Fort Lauderdale	Florida
United States	National Ophthalmic Research Institute	Fort Myers	Florida
United States	Retina Consultants of Orange County	Fullerton	California
United States	Colorado Retina Associates PC	Golden	Colorado
United States	Long Island Vitreoretinal Consultants	Great Neck	New York
United States	Retina Consultants of Houston	Houston	Texas
United States	Raj K. Maturi, MD, PC	Indianapolis	Indiana
United States	Eye Care Specialists	Kingston	Pennsylvania
United States	Southeastern Retina Associates	Knoxville	Tennessee
United States	University Retina and Macula Associates, PC	Lemont	Illinois
United States	Loma Linda University Health	Loma Linda	California
United States	University of California Los Angeles	Los Angeles	California
United States	Georgia Retina PC	Marietta	Georgia
United States	Florida Eye Associates	Melbourne	Florida
United States	Vitreoretinal Surgery PA	Minneapolis	Minnesota
United States	Northern California Retina Vitreous Associates	Mountain View	California
United States	Tennessee Retina	Nashville	Tennessee
United States	Vitreous Retina Macula Consultants of NY	New York	New York
United States	Retina Institute of California	Palm Desert	California
United States	California Eye Specialists	Pasadena	California
United States	Retina Specialty Institute	Pensacola	Florida
United States	Retinovitreous Associates	Philadelphia	Pennsylvania
United States	Associated Retina Consultants	Phoenix	Arizona
United States	Retina Consultants San Diego	Poway	California
United States	Black Hills Regional Eye Institute	Rapid City	South Dakota
United States	Sierra Eye Associates	Reno	Nevada
United States	Associated Retina Consultants PC	Royal Oak	Michigan
United States	Retinal Consultants Medical Group Inc	Sacramento	California
United States	University of California San Francisco	San Francisco	California
United States	Orange County Retina Medical Group	Santa Ana	California
United States	California Retina Consultants	Santa Barbara	California
United States	Retina Associates, PA	Shawnee Mission	Kansas
United States	Deep Blue Retina Clinical Research	Southaven	Mississippi
United States	Spokane Eye Clinical Research	Spokane	Washington
United States	Cascade Medical Research Institute	Springfield	Oregon
United States	Southern Vitreoretinal Associates	Tallahassee	Florida
United States	Retina Vitreous Associates of Florida	Tampa	Florida
United States	Retina Consultants of Houston	The Woodlands	Texas
United States	Associated Retina Consultants PC	Traverse City	Michigan
United States	Albany Troy Cataract & Laser Associates	Troy	New York
United States	New England Retina Associates PC	Waterford	Connecticut
United States	Strategic Clinical Research Group, LLC	Willow Park	Texas

Sponsors (1)

Lead Sponsor	Collaborator
NGM Biopharmaceuticals, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of change in GA lesion area as measured by fundus autofluorescence (FAF) over the 52 weeks of treatment	The primary efficacy endpoint	52 Weeks
Primary	The incidence and severity of ocular and systemic adverse events from treatment with NGM621 administered every 4 or 8 weeks compared to Sham	The primary safety endpoints	52 Weeks