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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)

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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

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.

Condition or disease Intervention/treatment Phase
Geographic Atrophy Biological: NGM621 Other: Sham Comparator Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)
Actual Study Start Date : July 22, 2020
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : April 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: NGM621 Treatment Group A (every 4 weeks)
NGM621 single IVT injection
Biological: NGM621
NGM621 Dose 1

Experimental: NGM621 Treatment Group C (every 8 weeks)
NGM621 single IVT injection
Biological: NGM621
NGM621 Dose 2

Sham Comparator: Sham Group B (every 4 wks) & D (every 8 wks)
Sham
Other: Sham Comparator
Sham Comparator




Primary Outcome Measures :
  1. 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

  2. The incidence and severity of ocular and systemic adverse events [ Time Frame: 48 Weeks ]
    The primary safety endpoints



Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04465955


Contacts
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Contact: NGM Study Director 650-243-5555 CATALINA@ngmbio.com

Locations
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Sponsors and Collaborators
NGM Biopharmaceuticals, Inc
Investigators
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Study Director: NGM Study Director NGM Biopharmaceuticals
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Responsible Party: NGM Biopharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT04465955    
Other Study ID Numbers: 621-GA-201
First Posted: July 10, 2020    Key Record Dates
Last Update Posted: December 2, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Geographic Atrophy
Atrophy
Pathological Conditions, Anatomical
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases