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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04014777

Enrollment

Registered

2019-07-10

Start date

2019-07-26

Completion date

2020-05-27

Last updated

2020-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Geographic Atrophy

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.

Interventions

BIOLOGICALNGM621

NGM621 Dose 1

Study design

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

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/

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026