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Completed

NCT Number: NCT04014777

Study of NGM621 in Participants With Geographic Atrophy

This is a multi-center evaluation of NGM621 in an open-label, single-dose and multiple-dose escalation study in participants with Geographic Atrophy secondary to Age-related Macular Degeneration.

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Key information

Conditions

Geographic Atrophy Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

NGM Clinical Study Site, Arcadia, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • GA lesion size in the study eye of >=2.5 mm² as assessed by the central reading center
  • BCVA - 54 to 4 letters (20/80 to 20/400 Snellen equivalent) using the standard ETDRS (Early Treatment of Diabetic Retinopathy Study) in the study eye at the Screening and Baseline visits; the fellow eye must have a BCVA of at least 69 letters (Snellen equivalent 20/40) at the Screening and Baseline visits

Exclusion criteria

  • GA in either eye because of cause other than AMD
  • History or evidence of glaucoma or ocular hypertension in either eye as defined by investigator
  • Visual impairment in the study eye due to causes other than GA
  • Spherical equivalent of the refractive error in the study eye demonstrating more than -6 Diopters of myopia (prior to cataract or refractive surgery)

Other protocol-defined inclusion/exclusion criteria could apply.

Treatment and study plan

NGM621

Biological

NGM621 Dose 1

Primary outcomes

  1. Incidence and Severity of Ocular and Systemic Treatment-Emergent Adverse Events (TEAEs)

    Time frame: 12 weeks

    The number and percent of patients reporting treatment emergent adverse events (TEAEs) by cohort.

Secondary outcomes

  1. Serum Concentration of NGM621

    Time frame: 12 weeks

    Individual and mean serum NGM621 concentration data by cohort.

Sponsors and collaborators

Lead sponsor

NGM Biopharmaceuticals, Inc

Industry

Registry information

Official study title

A Phase 1, Multicenter, Open-Label, Single-Dose and Multiple-Dose Escalation Study of the Safety, Tolerability, and Pharmacokinetics of Intravitreal Injections of NGM621 in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jul 10, 2019
Registry last updated
Oct 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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