Summary

Eligibility
for people ages 55 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion

Description

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.

Official Title

A Phase 2 Multicenter, Randomized, Double-Masked, Sham-Controlled Study of the Safety and Efficacy of Intravitreal Injections of NGM621 in Subjects With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)

Keywords

Geographic Atrophy Atrophy NGM621

Eligibility

You can join if…

Open to people ages 55 years and up

  • 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

You CAN'T join if...

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

Locations

  • University of California San Francisco accepting new patients
    San Francisco California 94143 United States
  • Northern California Retina Vitreous Associates accepting new patients
    Mountain View California 94040 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
NGM Biopharmaceuticals, Inc
ID
NCT04465955
Phase
Phase 2
Study Type
Interventional
Last Updated