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Study of NGM621 in Participants With Geographic Atrophy

Sponsor
NGM Biopharmaceuticals, Inc (Industry)
Overall Status
Completed
CT.gov ID
NCT04014777
Collaborator
(none)
15
Enrollment
6
Locations
4
Arms
10.1
Actual Duration (Months)
2.5
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: NGM621
  • Biological: NGM621
  • Biological: NGM621
  • Biological: NGM621
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
15 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jul 26, 2019
Actual Primary Completion Date :
May 27, 2020
Actual Study Completion Date :
May 27, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: NGM621 Cohort 1 Single Ascending Dose

NGM621 single IVT injection Cohort-Dose 1

Biological: NGM621
NGM621 Dose 1
Experimental: NGM621 Cohort 2 Single Ascending Dose

NGM621 single IVT injection Cohort--Dose 2

Biological: NGM621
NGM621 Dose 2
Experimental: NGM621 Cohort 3 Single Ascending Dose

NGM621 single IVT injection Cohort--Dose 3

Biological: NGM621
NGM621 Dose 3
Experimental: NGM621 Cohort 4 Multiple Dose

NGM621 multiple IVT injection Cohort--Dose 4

Biological: NGM621
NGM621 Dose 4

Outcome Measures

Primary Outcome Measures

  1. Incidence and Severity of Ocular and Systemic Treatment-Emergent Adverse Events (TEAEs) [12 weeks]

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

Secondary Outcome Measures

  1. Serum Concentration of NGM621 [12 weeks]

    Individual and mean serum NGM621 concentration data by cohort.

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 NGM Clinical Study Site Arcadia California United States 91007
2 NGM Clinical Study Site Newport Beach California United States 92663
3 NGM Clinical Study Site Melbourne Florida United States 32901
4 NGM Clinical Study Site Saint Petersburg Florida United States 33711
5 NGM Clinical Study Site Austin Texas United States 78705
6 NGM Clinical Study Site The Woodlands Texas United States 77384

Sponsors and Collaborators

  • NGM Biopharmaceuticals, Inc

Investigators

  • Study Director: NGM Study Director, NGM Biopharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
NGM Biopharmaceuticals, Inc
ClinicalTrials.gov Identifier:
NCT04014777
Other Study ID Numbers:
  • 18-0501
First Posted:
Jul 10, 2019
Last Update Posted:
Oct 1, 2020
Last Verified:
Sep 1, 2020
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Geographic Atrophy
Atrophy

Study Results

No Results Posted as of Oct 1, 2020