Study of NGM621 in Participants With Geographic Atrophy
NCT ID: NCT04014777
Last Updated: 2020-10-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
15 participants
INTERVENTIONAL
2019-07-26
2020-05-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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NGM621 Cohort 1 Single Ascending Dose
NGM621 single IVT injection Cohort-Dose 1
NGM621
NGM621 Dose 1
NGM621 Cohort 2 Single Ascending Dose
NGM621 single IVT injection Cohort--Dose 2
NGM621
NGM621 Dose 2
NGM621 Cohort 3 Single Ascending Dose
NGM621 single IVT injection Cohort--Dose 3
NGM621
NGM621 Dose 3
NGM621 Cohort 4 Multiple Dose
NGM621 multiple IVT injection Cohort--Dose 4
NGM621
NGM621 Dose 4
Interventions
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NGM621
NGM621 Dose 1
NGM621
NGM621 Dose 2
NGM621
NGM621 Dose 3
NGM621
NGM621 Dose 4
Eligibility Criteria
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Inclusion Criteria
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
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)
50 Years
ALL
No
Sponsors
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NGM Biopharmaceuticals, Inc
INDUSTRY
Responsible Party
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Principal Investigators
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NGM Study Director
Role: STUDY_DIRECTOR
NGM Biopharmaceuticals
Locations
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NGM Clinical Study Site
Arcadia, California, United States
NGM Clinical Study Site
Newport Beach, California, United States
NGM Clinical Study Site
Melbourne, Florida, United States
NGM Clinical Study Site
St. Petersburg, Florida, United States
NGM Clinical Study Site
Austin, Texas, United States
NGM Clinical Study Site
The Woodlands, Texas, United States
Countries
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Other Identifiers
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18-0501
Identifier Type: -
Identifier Source: org_study_id
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