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 an open-label, single-dose and multiple-dose escalation study in participants with Geographic Atrophy secondary to Age-related Macular Degeneration.

Official Title
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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

Conditions
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Geographic Atrophy

Intervention / Treatment
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* Biological: NGM621
* Biological: NGM621
* Biological: NGM621
* Biological: NGM621


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: GA lesion size in the study eye of >=2.5 mm² as assessed by the central reading center 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: GA in either eye because of cause other than AMD History or evidence of glaucoma or ocular hypertension in either eye as defined by investigator Visual impairment in the study eye due to causes other than GA 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.

Ages Eligible for Study
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Minimum Age: 50 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: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NGM621 Cohort 1 Single Ascending Dose<br>NGM621 single IVT injection Cohort-Dose 1 | Biological: NGM621<br>* NGM621 Dose 1<br>|
| Experimental: NGM621 Cohort 2 Single Ascending Dose<br>NGM621 single IVT injection Cohort--Dose 2 | Biological: NGM621<br>* NGM621 Dose 2<br>|
| Experimental: NGM621 Cohort 3 Single Ascending Dose<br>NGM621 single IVT injection Cohort--Dose 3 | Biological: NGM621<br>* NGM621 Dose 3<br>|
| Experimental: NGM621 Cohort 4 Multiple Dose<br>NGM621 multiple IVT injection Cohort--Dose 4 | Biological: NGM621<br>* NGM621 Dose 4<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum Concentration of NGM621 | Individual and mean serum NGM621 concentration data by cohort. | 12 weeks |