Study of NGM621 in Participants With Geographic Atrophy
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
1 other identifier
interventional
15
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jul 2019
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 3, 2019
CompletedFirst Posted
Study publicly available on registry
July 10, 2019
CompletedStudy Start
First participant enrolled
July 26, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 27, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 27, 2020
CompletedOctober 1, 2020
September 1, 2020
10 months
July 3, 2019
September 29, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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.
12 weeks
Secondary Outcomes (1)
Serum Concentration of NGM621
12 weeks
Study Arms (4)
NGM621 Cohort 1 Single Ascending Dose
EXPERIMENTALNGM621 single IVT injection Cohort-Dose 1
NGM621 Cohort 2 Single Ascending Dose
EXPERIMENTALNGM621 single IVT injection Cohort--Dose 2
NGM621 Cohort 3 Single Ascending Dose
EXPERIMENTALNGM621 single IVT injection Cohort--Dose 3
NGM621 Cohort 4 Multiple Dose
EXPERIMENTALNGM621 multiple IVT injection Cohort--Dose 4
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
NGM Clinical Study Site
Arcadia, California, 91007, United States
NGM Clinical Study Site
Newport Beach, California, 92663, United States
NGM Clinical Study Site
Melbourne, Florida, 32901, United States
NGM Clinical Study Site
St. Petersburg, Florida, 33711, United States
NGM Clinical Study Site
Austin, Texas, 78705, United States
NGM Clinical Study Site
The Woodlands, Texas, 77384, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
NGM Study Director
NGM Biopharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 3, 2019
First Posted
July 10, 2019
Study Start
July 26, 2019
Primary Completion
May 27, 2020
Study Completion
May 27, 2020
Last Updated
October 1, 2020
Record last verified: 2020-09