A Study of NGM621 in Participants With Geographic Atrophy

ID#: NCT04465955

Age: 55 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: Phase 2

Recruitment Status: Recruiting

Start Date: July 22, 2020

End Date: April 01, 2023

Contact Information:
NGM Study Director
650-243-5555
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:

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:

1. Total GA area must be ≥ 2.5 and ≤ 17.5 mm²

2. 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

3. 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
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