Study of NGM621 in Participants With Geographic Atrophy

NGM Biopharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Geographic Atrophy

Treatments: Biological: NGM621

Study type: Interventional

Funder types: Industry

Identifiers

NCT04014777

18-0501

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 50+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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15 participants in 4 patient groups

NGM621 Cohort 1 Single Ascending Dose

Experimental group

Description:

NGM621 single IVT injection Cohort-Dose 1

Treatment:

Biological: NGM621

Biological: NGM621

Biological: NGM621

Biological: NGM621

NGM621 Cohort 2 Single Ascending Dose

Experimental group

Description:

NGM621 single IVT injection Cohort--Dose 2

Treatment:

Biological: NGM621

Biological: NGM621

Biological: NGM621

Biological: NGM621

NGM621 Cohort 3 Single Ascending Dose

Experimental group

Description:

NGM621 single IVT injection Cohort--Dose 3

Treatment:

Biological: NGM621

Biological: NGM621

Biological: NGM621

Biological: NGM621

NGM621 Cohort 4 Multiple Dose

Experimental group

Description:

NGM621 multiple IVT injection Cohort--Dose 4

Treatment:

Biological: NGM621

Biological: NGM621

Biological: NGM621

Biological: NGM621