Study of NGM621 in Participants With Geographic Atrophy

September 29, 2020 updated by: NGM Biopharmaceuticals, Inc

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Arcadia, California, United States, 91007
        • NGM Clinical Study Site
      • Newport Beach, California, United States, 92663
        • NGM Clinical Study Site
    • Florida
      • Melbourne, Florida, United States, 32901
        • NGM Clinical Study Site
      • Saint Petersburg, Florida, United States, 33711
        • NGM Clinical Study Site
    • Texas
      • Austin, Texas, United States, 78705
        • NGM Clinical Study Site
      • The Woodlands, Texas, United States, 77384
        • NGM Clinical Study Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NGM621 Cohort 1 Single Ascending Dose
NGM621 single IVT injection Cohort-Dose 1
Biological: NGM621
NGM621 Dose 1
Biological: NGM621
NGM621 Dose 2
Biological: NGM621
NGM621 Dose 3
Biological: NGM621
NGM621 Dose 4
Experimental: NGM621 Cohort 2 Single Ascending Dose
NGM621 single IVT injection Cohort--Dose 2
Biological: NGM621
NGM621 Dose 1
Biological: NGM621
NGM621 Dose 2
Biological: NGM621
NGM621 Dose 3
Biological: NGM621
NGM621 Dose 4
Experimental: NGM621 Cohort 3 Single Ascending Dose
NGM621 single IVT injection Cohort--Dose 3
Biological: NGM621
NGM621 Dose 1
Biological: NGM621
NGM621 Dose 2
Biological: NGM621
NGM621 Dose 3
Biological: NGM621
NGM621 Dose 4
Experimental: NGM621 Cohort 4 Multiple Dose
NGM621 multiple IVT injection Cohort--Dose 4
Biological: NGM621
NGM621 Dose 1
Biological: NGM621
NGM621 Dose 2
Biological: NGM621
NGM621 Dose 3
Biological: NGM621
NGM621 Dose 4

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NGM Biopharmaceuticals, Inc

Investigators

  • Study Director: NGM Study Director, NGM Biopharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 26, 2019

Primary Completion (Actual)

May 27, 2020

Study Completion (Actual)

May 27, 2020

Study Registration Dates

First Submitted

July 3, 2019

First Submitted That Met QC Criteria

July 8, 2019

First Posted (Actual)

July 10, 2019

Study Record Updates

Last Update Posted (Actual)

October 1, 2020

Last Update Submitted That Met QC Criteria

September 29, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18-0501

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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