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Trial record 2 of 3 for:    NGM621
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Study of NGM621 in Participants With Geographic Atrophy

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ClinicalTrials.gov Identifier: NCT04014777
Recruitment Status : Completed
First Posted : July 10, 2019
Last Update Posted : October 1, 2020
Sponsor:
Information provided by (Responsible Party):
NGM Biopharmaceuticals, Inc

Study Description
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Brief Summary:
This is a multi-center evaluation of NGM621 in an open-label, single-dose and multiple-dose escalation study in participants with Geographic Atrophy secondary to Age-related Macular Degeneration.

Condition or disease Intervention/treatment Phase
Geographic Atrophy Biological: NGM621 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Multicenter, Open-Label, Single-Dose and Multiple-Dose Escalation Study of the Safety, Tolerability, and Pharmacokinetics of Intravitreal Injections of NGM621 in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration
Actual Study Start Date : July 26, 2019
Actual Primary Completion Date : May 27, 2020
Actual Study Completion Date : May 27, 2020

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Arms and Interventions
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Arm Intervention/treatment
Experimental: NGM621 Cohort 1 Single Ascending Dose
NGM621 single IVT injection Cohort-Dose 1
 Biological: NGM621
NGM621 Dose 1
Experimental: NGM621 Cohort 2 Single Ascending Dose
NGM621 single IVT injection Cohort--Dose 2
 Biological: NGM621
NGM621 Dose 2
Experimental: NGM621 Cohort 3 Single Ascending Dose
NGM621 single IVT injection Cohort--Dose 3
 Biological: NGM621
NGM621 Dose 3
Experimental: NGM621 Cohort 4 Multiple Dose
NGM621 multiple IVT injection Cohort--Dose 4
 Biological: NGM621
NGM621 Dose 4


Outcome Measures
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Primary Outcome Measures :
  1. Incidence and Severity of Ocular and Systemic Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: 12 weeks ]
    The number and percent of patients reporting treatment emergent adverse events (TEAEs) by cohort.


Secondary Outcome Measures :
  1. Serum Concentration of NGM621 [ Time Frame: 12 weeks ]
    Individual and mean serum NGM621 concentration data by cohort.


Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. GA lesion size in the study eye of >=2.5 mm² as assessed by the central reading center
  2. BCVA - 54 to 4 letters (20/80 to 20/400 Snellen equivalent) using the standard ETDRS (Early Treatment of Diabetic Retinopathy Study) in the study eye at the Screening and Baseline visits; the fellow eye must have a BCVA of at least 69 letters (Snellen equivalent 20/40) at the Screening and Baseline visits

Exclusion Criteria:

  1. GA in either eye because of cause other than AMD
  2. History or evidence of glaucoma or ocular hypertension in either eye as defined by investigator
  3. Visual impairment in the study eye due to causes other than GA
  4. Spherical equivalent of the refractive error in the study eye demonstrating more than -6 Diopters of myopia (prior to cataract or refractive surgery)

Other protocol-defined inclusion/exclusion criteria could apply.

Contacts and Locations
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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): NCT04014777


Locations
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United States, California
NGM Clinical Study Site
Arcadia, California, United States, 91007
NGM Clinical Study Site
Newport Beach, California, United States, 92663
United States, Florida
NGM Clinical Study Site
Melbourne, Florida, United States, 32901
NGM Clinical Study Site
Saint Petersburg, Florida, United States, 33711
United States, Texas
NGM Clinical Study Site
Austin, Texas, United States, 78705
NGM Clinical Study Site
The Woodlands, Texas, United States, 77384
Sponsors and Collaborators
NGM Biopharmaceuticals, Inc
Investigators
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Study Director: NGM Study Director NGM Biopharmaceuticals
More Information
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Responsible Party: NGM Biopharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT04014777    
Other Study ID Numbers: 18-0501
First Posted: July 10, 2019    Key Record Dates
Last Update Posted: October 1, 2020
Last Verified: September 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