A Study of NGM621 in Participants With Geographic Atrophy

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Geographic Atrophy

Intervention / Treatment
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* Biological: NGM621
* Biological: NGM621
* Other: Sham Comparator


Participation Criteria
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Eligibility Criteria
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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: Total GA area must be ≥ 2.5 and ≤ 17.5 mm² 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 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

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NGM621 Treatment Group A (every 4 weeks)<br>NGM621 single intravitreal (IVT) injection | Biological: NGM621<br>* NGM621 Dose 1<br>|
| Experimental: NGM621 Treatment Group C (every 8 weeks)<br>NGM621 single IVT injection | Biological: NGM621<br>* NGM621 Dose 2<br>|
| Sham Comparator: Sham Group B (every 4 weeks)<br>Sham single IVT injection | Other: Sham Comparator<br>* Sham Comparator<br>|
| Sham Comparator: Sham Group D (every 8 weeks)<br>Sham single IVT injection | Other: Sham Comparator<br>* Sham Comparator<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of change in GA lesion area as measured by fundus autofluorescence (FAF) over the 52 weeks of treatment | The primary efficacy endpoint | 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 | The primary safety endpoints | 52 Weeks |