Study of NGM621 in Participants With Geographic Atrophy

Completed · Phase 1

Conditions studied: Geographic Atrophy

In brief

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.

Key facts

Study ID: NCT04014777
Run by: NGM Biopharmaceuticals, Inc
People needed: 15
Starts: 2019-07-26
Expected to finish: 2020-05-27
Last updated by the study team: 2020-10-01

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

GA lesion size in the study eye of >=2.5 mm² as assessed by the central reading center
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

You may not qualify if…

GA in either eye because of cause other than AMD
History or evidence of glaucoma or ocular hypertension in either eye as defined by investigator
Visual impairment in the study eye due to causes other than GA
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.

Where it is running

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

Full record on ClinicalTrials.gov

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