A Study of NGM621 in Participants With Geographic Atrophy (CATALINA)

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)

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.

Study Overview

• Status: Completed
• Conditions: Geographic Atrophy
• Intervention / Treatment: Biological: NGM621; Biological: NGM621; Other: Sham Comparator

• Study Type: Interventional
• Enrollment (Actual): 320
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85020
      • Associated Retina Consultants
  • California
    • Bakersfield, California, United States, 93309
      • California Retina Consultants
    • Beverly Hills, California, United States, 90211
      • Retina Vitreous Associates
    • Campbell, California, United States, 95008
      • Retinal Diagnostic Center
    • Encino, California, United States, 91436
      • The Retina Partners
    • Fullerton, California, United States, 92835
      • Retina Consultants of Orange County
    • Loma Linda, California, United States, 92354
      • Loma Linda University Health
    • Los Angeles, California, United States, 90095
      • University of California Los Angeles
    • Mountain View, California, United States, 94040
      • Northern California Retina Vitreous Associates
    • Palm Desert, California, United States, 92260
      • Retina Institute of California
    • Pasadena, California, United States, 91107
      • California Eye Specialists
    • Poway, California, United States, 92064
      • Retina Consultants San Diego
    • Sacramento, California, United States, 95841
      • Retinal Consultants Medical Group Inc
    • San Francisco, California, United States, 94143
      • University of California San Francisco
    • Santa Ana, California, United States, 92705
      • Orange County Retina Medical Group
    • Santa Barbara, California, United States, 93103
      • California Retina Consultants
  • Colorado
    • Colorado Springs, Colorado, United States, 80909
      • Retina Consultants of Southern Colorado PC
    • Golden, Colorado, United States, 80401
      • Colorado Retina Associates PC
  • Connecticut
    • Waterford, Connecticut, United States, 06385
      • New England Retina Associates PC
  • Florida
    • Boynton Beach, Florida, United States, 33426
      • Florida Eye Microsurgical Institute
    • Coral Gables, Florida, United States, 33146
      • University of Miami
    • Coral Springs, Florida, United States, 33067
      • Specialty Retina Center (Coral Springs)
    • Fort Lauderdale, Florida, United States, 33308
      • Retina Group of Florida
    • Fort Myers, Florida, United States, 33912
      • National Ophthalmic Research Institute
    • Melbourne, Florida, United States, 32901
      • Florida Eye Associates
    • Pensacola, Florida, United States, 32503
      • Retina Specialty Institute
    • Tallahassee, Florida, United States, 32308
      • Southern Vitreoretinal Associates
    • Tampa, Florida, United States, 33607
      • Retina Vitreous Associates of Florida
  • Georgia
    • Marietta, Georgia, United States, 30060
      • Georgia Retina PC
  • Illinois
    • Bloomington, Illinois, United States, 61704
      • Gailey Eye Clinic - Bloomington
    • Chicago, Illinois, United States, 60612
      • University of Illinois
    • Lemont, Illinois, United States, 60439
      • University Retina and Macula Associates, PC
  • Indiana
    • Indianapolis, Indiana, United States, 46290
      • Raj K. Maturi, MD, PC
  • Kansas
    • Shawnee Mission, Kansas, United States, 66204
      • Retina Associates, PA
  • Maryland
    • Baltimore, Maryland, United States, 21204
      • Thompson Sjaarda, PA
    • Baltimore, Maryland, United States, 21237
      • Elman Retina Group PA
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Ophthalmic Consultants of Boston
  • Michigan
    • Royal Oak, Michigan, United States, 48073
      • Associated Retina Consultants PC
    • Traverse City, Michigan, United States, 49686
      • Associated Retina Consultants PC
  • Minnesota
    • Minneapolis, Minnesota, United States, 55435
      • Vitreoretinal Surgery PA
  • Mississippi
    • Southaven, Mississippi, United States, 38671
      • Deep Blue Retina Clinical Research
  • Nevada
    • Reno, Nevada, United States, 89502
      • Sierra Eye Associates
  • New York
    • Great Neck, New York, United States, 11021
      • Long Island Vitreoretinal Consultants
    • New York, New York, United States, 10022
      • Vitreous Retina Macula Consultants of NY
    • Troy, New York, United States, 12180
      • Albany Troy Cataract & Laser Associates
  • North Carolina
    • Asheville, North Carolina, United States, 18803
      • Western Carolina Retinal Associates
    • Charlotte, North Carolina, United States, 28210
      • Southeast Clinical Research
    • Durham, North Carolina, United States, 27705
      • Duke University
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Sterling Research Group, Ltd.
    • Cleveland, Ohio, United States, 44195
      • The Cleveland Clinic
    • Cleveland, Ohio, United States, 44122
      • Retina Associates of Cleveland
  • Oregon
    • Springfield, Oregon, United States, 97477
      • Cascade Medical Research Institute
  • Pennsylvania
    • Kingston, Pennsylvania, United States, 18704
      • Eye Care Specialists
    • Philadelphia, Pennsylvania, United States, 19107
      • Retinovitreous Associates
  • South Dakota
    • Rapid City, South Dakota, United States, 57701
      • Black Hills Regional Eye Institute
  • Tennessee
    • Knoxville, Tennessee, United States, 37922
      • Southeastern Retina Associates
    • Nashville, Tennessee, United States, 37203
      • Tennessee Retina
  • Texas
    • Arlington, Texas, United States, 76012
      • Texas Retina Associates
    • Dallas, Texas, United States, 75231
      • Retina Foundation of the Southwest
    • Dallas, Texas, United States, 75231
      • Texas Retina Associates-Plano
    • Houston, Texas, United States, 77030
      • Retina Consultants of Houston
    • The Woodlands, Texas, United States, 77384
      • Retina Consultants of Houston
    • Willow Park, Texas, United States, 76087
      • Strategic Clinical Research Group, LLC
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • University Of Virginia
  • Washington
    • Spokane, Washington, United States, 99204
      • Spokane Eye Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 53 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NGM621 Treatment Group C (every 8 weeks); NGM621 single IVT injection	Biological: NGM621; NGM621 Dose 1; Biological: NGM621; NGM621 Dose 2
Experimental: NGM621 Treatment Group A (every 4 weeks); NGM621 single intravitreal (IVT) injection	Biological: NGM621; NGM621 Dose 1; Biological: NGM621; NGM621 Dose 2
Sham Comparator: Sham Group B (every 4 weeks); Sham single IVT injection	Other: Sham Comparator; Sham Comparator
Sham Comparator: Sham Group D (every 8 weeks); Sham single IVT injection	Other: Sham Comparator; Sham Comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: NGM Biopharmaceuticals, Inc
• Investigators: Study Director: NGM Study Director, NGM Biopharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): July 22, 2020
• Primary Completion (Actual): August 16, 2022
• Study Completion (Actual): August 16, 2022

Study Registration Dates

• First Submitted: July 1, 2020
• First Submitted That Met QC Criteria: July 9, 2020
• First Posted (Actual): July 10, 2020

Study Record Updates

• Last Update Posted (Estimated): June 16, 2023
• Last Update Submitted That Met QC Criteria: June 13, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Pathological Conditions, Anatomical; Macular Degeneration; Geographic Atrophy; Atrophy
• Other Study ID Numbers: 621-GA-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Since the study did not meet the study endpoints, there is no plan to make IPD available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No