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A Study of NGM621 in Participants With Geographic Atrophy

About

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.

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase 2

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
55 Years
Maximum Age
N/A

Inclusion Criteria:

  • 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 Criteria:

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

Join this Trial

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Study Stats
Protocol No.
20-001231
Category
Ophthalmology
Contact
Rosaleen Ostrick
Location
  • UCLA Westwood
For Providers
NCT No.
NCT04465955
For detailed technical eligibility, visit ClinicalTrials.gov.