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Trial record 1 of 3 for:    NGM621
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A Study of NGM621 in Participants With Geographic Atrophy (CATALINA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04465955
Recruitment Status : Recruiting
First Posted : July 10, 2020
Last Update Posted : December 2, 2020
Sponsor:
Information provided by (Responsible Party):
NGM Biopharmaceuticals, Inc

Tracking Information
First Submitted Date  ICMJE July 1, 2020
First Posted Date  ICMJE July 10, 2020
Last Update Posted Date December 2, 2020
Actual Study Start Date  ICMJE July 22, 2020
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 9, 2020)
  • The change from baseline in the square root of GA lesion area at 48 weeks as measured by fundus autofluorescence (FAF) of NGM621 administered every 4 or 8 weeks compared to Sham. [ Time Frame: 48 Weeks ]
    The primary efficacy endpoint
  • The incidence and severity of ocular and systemic adverse events [ Time Frame: 48 Weeks ]
    The primary safety endpoints
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of NGM621 in Participants With Geographic Atrophy
Official Title  ICMJE 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)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Geographic Atrophy
Intervention  ICMJE
  • Biological: NGM621
    NGM621 Dose 1
  • Biological: NGM621
    NGM621 Dose 2
  • Other: Sham Comparator
    Sham Comparator
Study Arms  ICMJE
  • Experimental: NGM621 Treatment Group A (every 4 weeks)
    NGM621 single IVT injection
    Intervention: Biological: NGM621
  • Experimental: NGM621 Treatment Group C (every 8 weeks)
    NGM621 single IVT injection
    Intervention: Biological: NGM621
  • Sham Comparator: Sham Group B (every 4 wks) & D (every 8 wks)
    Sham
    Intervention: Other: Sham Comparator
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 9, 2020)		 240
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2023
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female (non-pregnant, non-lactating) subjects ≥ 55 years
  • Standard luminance BCVA of 34 letters or better using ETDRS charts at the distance of 4 meters (approximately 20/200 Snellen equivalent) 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 55 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: NGM Study Director 650-243-5555 CATALINA@ngmbio.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04465955
Other Study ID Numbers  ICMJE 621-GA-201
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party NGM Biopharmaceuticals, Inc
Study Sponsor  ICMJE NGM Biopharmaceuticals, Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: NGM Study Director NGM Biopharmaceuticals
PRS Account NGM Biopharmaceuticals, Inc
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP