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: 51 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 From Baseline in Geographic Atrophy (GA) Lesion Area	The rate of change from baseline in GA lesion area was measured by a non-invasive imaging technique called fundus autofluorescence (FAF) over the 52 weeks of treatment. FAF refers to the spontaneous emission of light by certain substances within the eye when exposed to a specific wavelength of light and involves quantifying the area and progression of atrophic lesions. The minimal GA lesion area is zero, the maximal GA lesion area is unknown. The higher the GA lesion area, the worse the visual outcome.	Baseline to Week 52
Number of Participants With Ocular Treatment-emergent Adverse Events in the Study Eye	A treatment-emergent adverse event (TEAE) was an adverse event (AE) that occurred during or after the first dose of study treatment.	Baseline to end of study (Week 56)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Change From Baseline in Geographic Atrophy (GA) Lesion Area	Geographic atrophy lesion area was measured by a non-invasive imaging technique called fundus autofluorescence (FAF). FAF refers to the spontaneous emission of light by certain substances within the eye when exposed to a specific wavelength of light and involves quantifying the area and progression of atrophic lesions. The minimal GA lesion area is zero, the maximal GA lesion area is unknown. The higher the GA lesion area, the worse the visual outcome.	Baseline up to Week 52
The Rate of Change From Baseline in the Square Root of Geographic Atropy (GA) Lesion Area	Geographic atrophy lesion area was measured by fundus autofluorescence (FAF). FAF refers to the spontaneous emission of light by certain substances within the eye when exposed to a specific wavelength of light and involves quantifying the area and progression of atrophic lesions.	Baseline up to Week 52
The Change From Baseline in Best Corrected Visual Acuity Score	Best Corrected Visual Acuity Score is the best possible vision an eye can achieve with corrective lenses, typically glasses or contact lenses. BCVA was assessed by the Early Treatment of Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. ETDRS letter score is calculated when >20 letters are read correctly at 4.0 meters; the visual acuity letter score is equal to the total number of letters read correctly at 4.0 meters plus 30. If <20 letters are read correctly at 4.0 meters, the visual acuity letter score is equal to the total number of letters read correctly at 4.0 meters (number of letters recorded on line 1.0), plus the total number of letters in the first six lines read correctly at 1.0 meter. Therefore, the ETDRS letter score could result in a score of 0-100, where lower scores indicate better vision. The change from baseline in BCVA is being report with negative scores indicating an improvement in vision.	Baseline up to Week 52
The Change From Baseline in Low Luminance Visual Acuity Score	Low Luminance Visual Acuity Score measures vision in low-light conditions. It was assessed by the Early Treatment of Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. ETDRS letter score is calculated when >20 letters are read correctly at 4.0 meters; the visual acuity letter score is equal to the total number of letters read correctly at 4.0 meters plus 30. If <20 letters are read correctly at 4.0 meters, the visual acuity letter score is equal to the total number of letters read correctly at 4.0 meters (number of letters recorded on line 1.0), plus the total number of letters in the first six lines read correctly at 1.0 meter. Therefore, the ETDRS letter score could result in a score of 0-100, where lower scores indicate better vision. A lower (negative) LLVA score compared to baseline indicates a decline in visual acuity. A higher (positive) LLVA score compared to baseline indicates an improvement in visual acuity.	Baseline up to Week 52
The Change From Baseline in Low Luminance Deficit Score	Low Luminance Deficit (LLD) Score was assessed by the Early Treatment of Diabetic Retinopathy Study (ETDRS) letters at a starting distance of 4 meters. ETDRS letter score is calculated when >20 letters are read correctly at 4.0 meters; the visual acuity letter score is equal to the total number of letters read correctly at 4.0 meters plus 30. If <20 letters are read correctly at 4.0 meters, the visual acuity letter score is equal to the total number of letters read correctly at 4.0 meters (number of letters recorded on line 1.0), plus the total number of letters in the first six lines read correctly at 1.0 meter. Therefore, the ETDRS letter score could result in a score of 0-100, where lower scores indicate better vision. A LLD is the difference between standard visual acuity and LLVA, with a LLD >13 ETDRS letters suggesting potential visual abnormality. The change from baseline in LLD is being report with negative scores indicating an improvement in vision.	Baseline up to Week 52
The Change From Baseline in Average Binocular Reading Speed	Average binocular reading speed was assessed by Minnesota Low-Vision Reading Test (MNRead) or Radner reading charts. The change from baseline in average binocular reading speed is reported with a higher (positive) reading speed (wpm) indicates better reading ability, while a lower (negative) reading speed indicates poorer reading ability.	Baseline up to Week 52
The Change From Baseline in Binocular Critical Print Size	Binocular critical print size was assessed by the Minnesota Low-Vision Reading Test (MNRead) or Radner reading charts. MNRead uses a logarithmic scale (LogMAR) to represent print sizes, with each step representing a 0.1 LogMAR difference. The chart ranges from +1.3 LogMAR (equivalent to 20/400 at 40 cm) to -0.5 LogMAR (equivalent to 20/6 at 40 cm). The change from baseline in binocular critical print size is being reported with a higher (positive) LogMAR value for critical print size indicating that a person needs larger print sizes to maintain their maximum reading speed, while a lower (negative) LogMAR value indicates that they can read smaller print sizes at their maximum speed.	Baseline up to Week 52
The Change From Baseline in Binocular Reading Acuity	Binocular reading acuity was assessed by the Minnesota Low-Vision Reading Test (MNRead) or Radner reading charts. MNRead uses a logarithmic scale (LogMAR) to represent print sizes, with each step representing a 0.1 LogMAR difference. The chart ranges from +1.3 LogMAR (equivalent to 20/400 at 40 cm) to -0.5 LogMAR (equivalent to 20/6 at 40 cm). Binocular reading acuity is the smallest print size (in LogMAR) that a person can read easily and accurately. The change from baseline in binocular reading acuity is being reported with a higher LogMAR value for reading acuity indicates poorer reading ability, while a lower LogMAR value indicates better reading ability.	Baseline up to Week 52
The Change From Baseline in Functional Reading Independence Index Composite Score	The Functional Reading Independence (FRI) Index Composite Score is a 7-item patient questionnaire developed to evaluate the effect of geography atrophy on a patient's ability to independently perform reading activities. The FRI Index yields mean scores ranging from 1-4, with 1=unable to do and 4=totally independent. The FRI Index composite score is calculated by averaging the item-level scores across the seven questions, higher sores indicate better FRI. The change from baseline in FRI is being reported with lower (negative) values indicating a decline in FRI.	Baseline up to Week 52
The Change From Baseline in National Eye Institute Visual Functioning Questionnaire Composite Score	The National Eye Institute Visual Functioning Questionnaire Composite Score is calculated by averaging the scores of the 11 vision-targeted subscales, excluding the general health rating question, on a scale of 0 to 100, with higher scores indicating better vision-related function. The change from baseline is being reported with a negative value indicating a decline in vision function.	Baseline up to Week 52
The Change From Baseline in Systemic Complement Activity (CH50)	Systemic Complement Activity is a blood test that measures the overall activity of the complement system, a group of proteins crucial for the immune system's function. Low CH50 levels can be associated with certain infections. CH50 levels of 41 to 90 hemolytic units per mL (U/mL) is considered normal. The change from baseline in CH50 is being reported.	Baseline up to Week 52
Number of Anti-Drug Antibody (ADA)-Negative Participants	The incidence of anti-drug antibody (ADA) was assessed in serum.	Baseline up to Week 52

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): July 1, 2025
• Last Update Submitted That Met QC Criteria: June 12, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Eye Diseases; Retinal Diseases; Retinal Degeneration; Macular Degeneration; Atrophy; Geographic 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