Study of NGM621 in Participants With Geographic Atrophy

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Sequential Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 2020

Interventions

  • Biological: NGM621
    • NGM621 Dose 1
  • Biological: NGM621
    • NGM621 Dose 2
  • Biological: NGM621
    • NGM621 Dose 3
  • Biological: NGM621
    • NGM621 Dose 4

Arms, Groups and Cohorts

  • Experimental: NGM621 Cohort 1 Single Ascending Dose
    • NGM621 single IVT injection Cohort-Dose 1
  • Experimental: NGM621 Cohort 2 Single Ascending Dose
    • NGM621 single IVT injection Cohort–Dose 2
  • Experimental: NGM621 Cohort 3 Single Ascending Dose
    • NGM621 single IVT injection Cohort–Dose 3
  • Experimental: NGM621 Cohort 4 Multiple Dose
    • NGM621 multiple IVT injection Cohort–Dose 4

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Serum Concentration of NGM621
    • Time Frame: 12 weeks
    • Individual and mean serum NGM621 concentration data by cohort.

Participating in This Clinical Trial

Inclusion Criteria

1. GA lesion size in the study eye of >=2.5 mm² as assessed by the central reading center

2. 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

1. GA in either eye because of cause other than AMD

2. History or evidence of glaucoma or ocular hypertension in either eye as defined by investigator

3. Visual impairment in the study eye due to causes other than GA

4. 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.

Gender Eligibility: All

Minimum Age: 50 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • NGM Biopharmaceuticals, Inc
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • NGM Study Director, Study Director, NGM Biopharmaceuticals
  • Overall Contact(s)
    • Bryan Baxter, 650-243-5555, bbaxter@ngmbio.com

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