Status:
COMPLETED
Study of NGM621 in Participants With Geographic Atrophy
Lead Sponsor:
NGM Biopharmaceuticals, Inc
Conditions:
Geographic Atrophy
Eligibility:
All Genders
50+ years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
July 26 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 27 2020
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04014777
Start Date
July 26 2019
End Date
May 27 2020
Last Update
October 1 2020
Active Locations (6)
Enter a location and click search to find clinical trials sorted by distance.
1
NGM Clinical Study Site
Arcadia, California, United States, 91007
2
NGM Clinical Study Site
Newport Beach, California, United States, 92663
3
NGM Clinical Study Site
Melbourne, Florida, United States, 32901
4
NGM Clinical Study Site
St. Petersburg, Florida, United States, 33711