Clinical trial

A Phase 2 Multicenter, Randomized, Double-Masked, Sham-Controlled Study of the Safety and Efficacy of Intravitreal Injections of NGM621 in Subjects With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)

Name

621-GA-201

Description

This is a multi-center evaluation of NGM621 in a randomized, double-masked, sham-controlled study in participants with Geographic Atrophy secondary to Age-related Macular Degeneration.

Trial arms

Trial start

2020-07-22

Estimated PCD

2022-08-16

Trial end

2022-08-16

Status

Completed

Phase

Early phase I

Treatment

NGM621

NGM621 Dose 1

Arms:

NGM621 Treatment Group A (every 4 weeks)

NGM621

NGM621 Dose 2

Arms:

NGM621 Treatment Group C (every 8 weeks)

Sham Comparator

Arms:

Sham Group B (every 4 weeks), Sham Group D (every 8 weeks)

Size

320

Primary endpoint

The rate of change in GA lesion area as measured by fundus autofluorescence (FAF) over the 52 weeks of treatment

52 Weeks

The incidence and severity of ocular and systemic adverse events from treatment with NGM621 administered every 4 or 8 weeks compared to Sham

52 Weeks

Eligibility criteria

Inclusion Criteria: * Male or female (non-pregnant, non-lactating) subjects ≥ 55 years * Standard luminance BCVA score of 34 letters or better using ETDRS charts at the starting distance of 4 meters (approximately 20/200 Snellen equivalent or better) in study eye * Clinical diagnosis of GA secondary to AMD: 1. Total GA area must be ≥ 2.5 and ≤ 17.5 mm² 2. If GA is multifocal, at least one focal lesion must be ≥ 1.25 mm² (0.5 DA), with the overall area of GA ≥ 2.5 and ≤ 17.5 mm² 3. Well demarcated GA with no anatomical evidence of current or prior CNV in the study eye Exclusion Criteria: Study Eye * GA secondary to a condition other than AMD in either eye (e.g., monogenetic macular dystrophies like Stargardt disease, cone rod dystrophy, or toxic maculopathies) * Any history of or active choroidal neovascularization (CNV) Both Eyes * Any history of or active bacterial, viral, fungal, or parasitic infection in either eye in the 3 months prior to randomization

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 320, 'type': 'ACTUAL'}}

Updated at

2023-06-18

1 organization

1 product

1 indication

Organization

NGM Biopharmaceuticals

Product

NGM621

Indication

Geographic Atrophy