Status:
COMPLETED
A Study of NGM621 in Participants With Geographic Atrophy
Lead Sponsor:
NGM Biopharmaceuticals, Inc
Conditions:
Geographic Atrophy
Eligibility:
All Genders
55+ years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- Male or female (non-pregnant, non-lactating) subjects ≥ 55 years
- Standard luminance BCVA score of 34 letters or better using ETDRS charts at the starting distance of 4 meters (approximately 20/200 Snellen equivalent or better) in study eye
- Clinical diagnosis of GA secondary to AMD:
- Total GA area must be ≥ 2.5 and ≤ 17.5 mm²
- 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
- Well demarcated GA with no anatomical evidence of current or prior CNV in the study eye
Exclusion
- 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
Key Trial Info
Start Date :
July 22 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 16 2022
Estimated Enrollment :
320 Patients enrolled
Trial Details
Trial ID
NCT04465955
Start Date
July 22 2020
End Date
August 16 2022
Last Update
July 1 2025
Active Locations (65)
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1
Associated Retina Consultants
Phoenix, Arizona, United States, 85020
2
California Retina Consultants
Bakersfield, California, United States, 93309
3
Retina Vitreous Associates
Beverly Hills, California, United States, 90211
4
Retinal Diagnostic Center
Campbell, California, United States, 95008