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

Primary Purpose

Geographic Atrophy

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
NGM621
NGM621
Sham Comparator
Sponsored by
NGM Biopharmaceuticals, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Geographic Atrophy

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Associated Retina Consultants
  • California Retina Consultants
  • Retina Vitreous Associates
  • Retinal Diagnostic Center
  • The Retina Partners
  • Retina Consultants of Orange County
  • Loma Linda University Health
  • University of California Los Angeles
  • Northern California Retina Vitreous Associates
  • Retina Institute of California
  • California Eye Specialists
  • Retina Consultants San Diego
  • Retinal Consultants Medical Group Inc
  • University of California San Francisco
  • Orange County Retina Medical Group
  • California Retina Consultants
  • Retina Consultants of Southern Colorado PC
  • Colorado Retina Associates PC
  • New England Retina Associates PC
  • Florida Eye Microsurgical Institute
  • University of Miami
  • Specialty Retina Center (Coral Springs)
  • Retina Group of Florida
  • National Ophthalmic Research Institute
  • Florida Eye Associates
  • Retina Specialty Institute
  • Southern Vitreoretinal Associates
  • Retina Vitreous Associates of Florida
  • Georgia Retina PC
  • Gailey Eye Clinic - Bloomington
  • University of Illinois
  • University Retina and Macula Associates, PC
  • Raj K. Maturi, MD, PC
  • Retina Associates, PA
  • Thompson Sjaarda, PA
  • Elman Retina Group PA
  • Ophthalmic Consultants of Boston
  • Associated Retina Consultants PC
  • Associated Retina Consultants PC
  • Vitreoretinal Surgery PA
  • Deep Blue Retina Clinical Research
  • Sierra Eye Associates
  • Long Island Vitreoretinal Consultants
  • Vitreous Retina Macula Consultants of NY
  • Albany Troy Cataract & Laser Associates
  • Western Carolina Retinal Associates
  • Southeast Clinical Research
  • Duke University
  • Sterling Research Group, Ltd.
  • Retina Associates of Cleveland
  • The Cleveland Clinic
  • Cascade Medical Research Institute
  • Eye Care Specialists
  • Retinovitreous Associates
  • Black Hills Regional Eye Institute
  • Southeastern Retina Associates
  • Tennessee Retina
  • Texas Retina Associates
  • Retina Foundation of the Southwest
  • Texas Retina Associates-Plano
  • Retina Consultants of Houston
  • Retina Consultants of Houston
  • Strategic Clinical Research Group, LLC
  • University of Virginia
  • Spokane Eye Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Sham Comparator

Sham Comparator

Arm Label

NGM621 Treatment Group A (every 4 weeks)

NGM621 Treatment Group C (every 8 weeks)

Sham Group B (every 4 weeks)

Sham Group D (every 8 weeks)

Arm Description

NGM621 single intravitreal (IVT) injection

NGM621 single IVT injection

Sham single IVT injection

Sham single IVT injection

Outcomes

Primary Outcome Measures

The rate of change in GA lesion area as measured by fundus autofluorescence (FAF) over the 52 weeks of treatment
The primary efficacy endpoint
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

Secondary Outcome Measures

Full Information

First Posted
July 1, 2020
Last Updated
June 13, 2023
Sponsor
NGM Biopharmaceuticals, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT04465955
Brief Title
A Study of NGM621 in Participants With Geographic Atrophy
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
July 22, 2020 (Actual)
Primary Completion Date
August 16, 2022 (Actual)
Study Completion Date
August 16, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NGM Biopharmaceuticals, Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Geographic Atrophy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
320 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NGM621 Treatment Group A (every 4 weeks)
Arm Type
Experimental
Arm Description
NGM621 single intravitreal (IVT) injection
Arm Title
NGM621 Treatment Group C (every 8 weeks)
Arm Type
Experimental
Arm Description
NGM621 single IVT injection
Arm Title
Sham Group B (every 4 weeks)
Arm Type
Sham Comparator
Arm Description
Sham single IVT injection
Arm Title
Sham Group D (every 8 weeks)
Arm Type
Sham Comparator
Arm Description
Sham single IVT injection
Intervention Type
Biological
Intervention Name(s)
NGM621
Intervention Description
NGM621 Dose 1
Intervention Type
Biological
Intervention Name(s)
NGM621
Intervention Description
NGM621 Dose 2
Intervention Type
Other
Intervention Name(s)
Sham Comparator
Intervention Description
Sham Comparator
Primary Outcome Measure Information:
Title
The rate of change in GA lesion area as measured by fundus autofluorescence (FAF) over the 52 weeks of treatment
Description
The primary efficacy endpoint
Time Frame
52 Weeks
Title
The incidence and severity of ocular and systemic adverse events from treatment with NGM621 administered every 4 or 8 weeks compared to Sham
Description
The primary safety endpoints
Time Frame
52 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: Total GA area must be ≥ 2.5 and ≤ 17.5 mm² 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
NGM Study Director
Organizational Affiliation
NGM Biopharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Associated Retina Consultants
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85020
Country
United States
Facility Name
California Retina Consultants
City
Bakersfield
State/Province
California
ZIP/Postal Code
93309
Country
United States
Facility Name
Retina Vitreous Associates
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Retinal Diagnostic Center
City
Campbell
State/Province
California
ZIP/Postal Code
95008
Country
United States
Facility Name
The Retina Partners
City
Encino
State/Province
California
ZIP/Postal Code
91436
Country
United States
Facility Name
Retina Consultants of Orange County
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
Loma Linda University Health
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
University of California Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Northern California Retina Vitreous Associates
City
Mountain View
State/Province
California
ZIP/Postal Code
94040
Country
United States
Facility Name
Retina Institute of California
City
Palm Desert
State/Province
California
ZIP/Postal Code
92260
Country
United States
Facility Name
California Eye Specialists
City
Pasadena
State/Province
California
ZIP/Postal Code
91107
Country
United States
Facility Name
Retina Consultants San Diego
City
Poway
State/Province
California
ZIP/Postal Code
92064
Country
United States
Facility Name
Retinal Consultants Medical Group Inc
City
Sacramento
State/Province
California
ZIP/Postal Code
95841
Country
United States
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Orange County Retina Medical Group
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
California Retina Consultants
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93103
Country
United States
Facility Name
Retina Consultants of Southern Colorado PC
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
Facility Name
Colorado Retina Associates PC
City
Golden
State/Province
Colorado
ZIP/Postal Code
80401
Country
United States
Facility Name
New England Retina Associates PC
City
Waterford
State/Province
Connecticut
ZIP/Postal Code
06385
Country
United States
Facility Name
Florida Eye Microsurgical Institute
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33426
Country
United States
Facility Name
University of Miami
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33146
Country
United States
Facility Name
Specialty Retina Center (Coral Springs)
City
Coral Springs
State/Province
Florida
ZIP/Postal Code
33067
Country
United States
Facility Name
Retina Group of Florida
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
National Ophthalmic Research Institute
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Facility Name
Florida Eye Associates
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32901
Country
United States
Facility Name
Retina Specialty Institute
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32503
Country
United States
Facility Name
Southern Vitreoretinal Associates
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
Retina Vitreous Associates of Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Facility Name
Georgia Retina PC
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Gailey Eye Clinic - Bloomington
City
Bloomington
State/Province
Illinois
ZIP/Postal Code
61704
Country
United States
Facility Name
University of Illinois
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University Retina and Macula Associates, PC
City
Lemont
State/Province
Illinois
ZIP/Postal Code
60439
Country
United States
Facility Name
Raj K. Maturi, MD, PC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46290
Country
United States
Facility Name
Retina Associates, PA
City
Shawnee Mission
State/Province
Kansas
ZIP/Postal Code
66204
Country
United States
Facility Name
Thompson Sjaarda, PA
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
Elman Retina Group PA
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21237
Country
United States
Facility Name
Ophthalmic Consultants of Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Associated Retina Consultants PC
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Associated Retina Consultants PC
City
Traverse City
State/Province
Michigan
ZIP/Postal Code
49686
Country
United States
Facility Name
Vitreoretinal Surgery PA
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Facility Name
Deep Blue Retina Clinical Research
City
Southaven
State/Province
Mississippi
ZIP/Postal Code
38671
Country
United States
Facility Name
Sierra Eye Associates
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
Facility Name
Long Island Vitreoretinal Consultants
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
Vitreous Retina Macula Consultants of NY
City
New York
State/Province
New York
ZIP/Postal Code
10022
Country
United States
Facility Name
Albany Troy Cataract & Laser Associates
City
Troy
State/Province
New York
ZIP/Postal Code
12180
Country
United States
Facility Name
Western Carolina Retinal Associates
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
18803
Country
United States
Facility Name
Southeast Clinical Research
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Sterling Research Group, Ltd.
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Retina Associates of Cleveland
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
The Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Cascade Medical Research Institute
City
Springfield
State/Province
Oregon
ZIP/Postal Code
97477
Country
United States
Facility Name
Eye Care Specialists
City
Kingston
State/Province
Pennsylvania
ZIP/Postal Code
18704
Country
United States
Facility Name
Retinovitreous Associates
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Black Hills Regional Eye Institute
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Facility Name
Southeastern Retina Associates
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37922
Country
United States
Facility Name
Tennessee Retina
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Texas Retina Associates
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Facility Name
Retina Foundation of the Southwest
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Texas Retina Associates-Plano
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Retina Consultants of Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Retina Consultants of Houston
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77384
Country
United States
Facility Name
Strategic Clinical Research Group, LLC
City
Willow Park
State/Province
Texas
ZIP/Postal Code
76087
Country
United States
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Facility Name
Spokane Eye Clinical Research
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Since the study did not meet the study endpoints, there is no plan to make IPD available to other researchers.

Learn more about this trial

A Study of NGM621 in Participants With Geographic Atrophy

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