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Study of NGM621 in Participants With Geographic Atrophy

Primary Purpose

Geographic Atrophy

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
NGM621
NGM621
NGM621
NGM621
Sponsored by
NGM Biopharmaceuticals, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Geographic Atrophy

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • NGM Clinical Study Site
  • NGM Clinical Study Site
  • NGM Clinical Study Site
  • NGM Clinical Study Site
  • NGM Clinical Study Site
  • NGM Clinical Study Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

NGM621 Cohort 1 Single Ascending Dose

NGM621 Cohort 2 Single Ascending Dose

NGM621 Cohort 3 Single Ascending Dose

NGM621 Cohort 4 Multiple Dose

Arm Description

NGM621 single IVT injection Cohort-Dose 1

NGM621 single IVT injection Cohort--Dose 2

NGM621 single IVT injection Cohort--Dose 3

NGM621 multiple IVT injection Cohort--Dose 4

Outcomes

Primary Outcome Measures

Incidence and Severity of Ocular and Systemic Treatment-Emergent Adverse Events (TEAEs)
The number and percent of patients reporting treatment emergent adverse events (TEAEs) by cohort.

Secondary Outcome Measures

Serum Concentration of NGM621
Individual and mean serum NGM621 concentration data by cohort.

Full Information

First Posted
July 3, 2019
Last Updated
September 29, 2020
Sponsor
NGM Biopharmaceuticals, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT04014777
Brief Title
Study of NGM621 in Participants With Geographic Atrophy
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
July 26, 2019 (Actual)
Primary Completion Date
May 27, 2020 (Actual)
Study Completion Date
May 27, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NGM Biopharmaceuticals, Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Geographic Atrophy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NGM621 Cohort 1 Single Ascending Dose
Arm Type
Experimental
Arm Description
NGM621 single IVT injection Cohort-Dose 1
Arm Title
NGM621 Cohort 2 Single Ascending Dose
Arm Type
Experimental
Arm Description
NGM621 single IVT injection Cohort--Dose 2
Arm Title
NGM621 Cohort 3 Single Ascending Dose
Arm Type
Experimental
Arm Description
NGM621 single IVT injection Cohort--Dose 3
Arm Title
NGM621 Cohort 4 Multiple Dose
Arm Type
Experimental
Arm Description
NGM621 multiple IVT injection Cohort--Dose 4
Intervention Type
Biological
Intervention Name(s)
NGM621
Intervention Description
NGM621 Dose 1
Intervention Type
Biological
Intervention Name(s)
NGM621
Intervention Description
NGM621 Dose 2
Intervention Type
Biological
Intervention Name(s)
NGM621
Intervention Description
NGM621 Dose 3
Intervention Type
Biological
Intervention Name(s)
NGM621
Intervention Description
NGM621 Dose 4
Primary Outcome Measure Information:
Title
Incidence and Severity of Ocular and Systemic Treatment-Emergent Adverse Events (TEAEs)
Description
The number and percent of patients reporting treatment emergent adverse events (TEAEs) by cohort.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Serum Concentration of NGM621
Description
Individual and mean serum NGM621 concentration data by cohort.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
NGM Study Director
Organizational Affiliation
NGM Biopharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
NGM Clinical Study Site
City
Arcadia
State/Province
California
ZIP/Postal Code
91007
Country
United States
Facility Name
NGM Clinical Study Site
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
NGM Clinical Study Site
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32901
Country
United States
Facility Name
NGM Clinical Study Site
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33711
Country
United States
Facility Name
NGM Clinical Study Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
NGM Clinical Study Site
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77384
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Study of NGM621 in Participants With Geographic Atrophy

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