Study of NGM621 in Participants With Geographic Atrophy

Geographic Atrophy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04014777
• Other study ID #: 18-0501
• Status: Completed
• Phase: Phase 1
• Start date: July 26, 2019
• Est. completion date: May 27, 2020

Study information

• Verified date: September 2020
• Source: NGM Biopharmaceuticals, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: May 27, 2020
• Est. primary completion date: May 27, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrophy
• Geographic Atrophy

Intervention

Biological:
• NGM621
NGM621 Dose 1
• NGM621
NGM621 Dose 2
• NGM621
NGM621 Dose 3
• NGM621
NGM621 Dose 4

Locations

Country	Name	City	State
United States	NGM Clinical Study Site	Arcadia	California
United States	NGM Clinical Study Site	Austin	Texas
United States	NGM Clinical Study Site	Melbourne	Florida
United States	NGM Clinical Study Site	Newport Beach	California
United States	NGM Clinical Study Site	Saint Petersburg	Florida
United States	NGM Clinical Study Site	The Woodlands	Texas

Sponsors (1)

Lead Sponsor	Collaborator
NGM Biopharmaceuticals, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Serum Concentration of NGM621	Individual and mean serum NGM621 concentration data by cohort.	12 weeks