Study of NGM621 in Participants With Geographic Atrophy

Phase 1

Completed

• Conditions: Geographic Atrophy
• Interventions: Biological: NGM621

• Registration Number: NCT04014777
• Lead Sponsor: NGM Biopharmaceuticals, Inc

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-07-03
• Study First Submitted QC: 2019-07-08
• Study First Posted: 2019-07-10
• Study Start: 2019-07-26
• Primary Completion: 2020-05-27
• Study Completion: 2020-05-27
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-29
• Last Update Posted: 2020-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
NGM621 Cohort 1 Single Ascending Dose	NGM621	NGM621 single IVT injection Cohort-Dose 1
NGM621 Cohort 3 Single Ascending Dose	NGM621	NGM621 single IVT injection Cohort--Dose 3
NGM621 Cohort 2 Single Ascending Dose	NGM621	NGM621 single IVT injection Cohort--Dose 2
NGM621 Cohort 4 Multiple Dose	NGM621	NGM621 multiple IVT injection Cohort--Dose 4

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Serum Concentration of NGM621	12 weeks	Individual and mean serum NGM621 concentration data by cohort.

Trial Locations

Locations (1)

NGM Clinical Study Site; 🇺🇸 The Woodlands, Texas, United States