A Study of NGM621 in Participants With Geographic Atrophy

  • STATUS
    Recruiting
  • participants needed
    240
  • sponsor
    NGM Biopharmaceuticals, Inc
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Updated on 5 August 2020
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age-related macular degeneration
atrophy
macular degeneration
maculopathy

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.

Details
Condition Dry Macular Degeneration, age-related macular degeneration, macular degeneration, macular degeneration, geographic atrophy
Age 55years - 88years
Treatment Sham comparator, NGM621
Clinical Study IdentifierNCT04465955
SponsorNGM Biopharmaceuticals, Inc
Last Modified on5 August 2020

Eligibility

 Yes No Not Sure

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)
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