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A Study of NGM621 in Participants With Geographic Atrophy

A Study of NGM621 in Participants With Geographic Atrophy

Recruiting
55-88 years
All
Phase 2

Overview

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

Inclusion Criteria:

  • Standard luminance BCVA of 49 letters or better using ETDRS charts at the distance of 4 meters (approximately 20/100 Snellen equivalent) in study eye
  • If the BCVA letter score is 79 letters (Snellen equivalent of 20/25 or better), at least one GA lesion must be within 250 m of the foveal center

Exclusion Criteria:

  • History of prior intravitreal injection, vitrectomy surgery, submacular surgery, or any surgical intervention for AMD. A single intraoperative administration of a corticosteroid during cataract surgery for cystoid macular edema prophylaxis at least 3 months prior to screening is permitted
  • GA secondary to a condition other than AMD in either eye (e.g., monogenetic macular dystrophies (Stargardt disease, cone rod dystrophy), toxic maculopathies)
  • Any history of or active bacterial, viral, fungal, or parasitic infection in either eye in the 3 months prior to randomization
  • Any history of or active choroidal neovascularization (CNV) in either eye, based on fluorescein angiography (FA) and on OCT or OCT-A imaging as assessed by the Central Reading Center (CRC)

Study details
    Dry Macular Degeneration
    age-related macular degeneration
    macular degeneration
    macular degeneration
    geographic atrophy

NCT04465955

NGM Biopharmaceuticals, Inc

5 August 2020

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