Study of VOY-101 in Patients With Advanced Non-Neovascular Age-Related Macular Degeneration

Study Overview
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Brief Summary
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This safety study comprises a dose escalation study of VOY-101, followed by a cohort of subjects randomized to the maximum tolerated dose arm, a lower dose arm, and control arm.

Detailed Description
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This is a prospective, multi-center safety phase 1/2a study to evaluate the safety of a single, unilateral intravitreal (IVT) injection of three dose levels of VOY-101 therapy in subjects with late-stage non-neovascular age-related macular degeneration (AMD).

Official Title
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Phase 1/2a Dose Escalation Study of VOY-101 in Patients With Advanced Non-Neovascular Age-Related Macular Degeneration

Conditions
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Age-related Macular Degeneration, Geographic Atrophy

Intervention / Treatment
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* Biological: VOY-101


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Are ≥50 years of age at the time of consent. Are willing and able to understand and provide written informed consent. Are willing and able to return for scheduled treatment and follow-up examinations. Are able to undergo ETDRS BCDVA testing and ophthalmic imaging. Well-demarcated GA secondary to AMD in the absence of MNV and in the absence of history of MNV. Absence of signs of non-exudative MNV. Additional Ocular Inclusion Criteria Meet certain genotype criteria for risk of AMD. Exclusion Criteria: Are women of childbearing potential (WOCBP) and are pregnant or unwilling to use and document use of effective contraception for the duration of the study. Additional Systemic, Ocular, and Genetic Exclusion Criteria.

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: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: The Phase 1 will enroll in a dose escalation study model (three sequential cohorts), followed by a Phase 2a cohort that will be randomized among a maximum tolerated dose arm, a lower dose arm, and a control arm.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low Dose<br>VOY-101 Low Dose (single dose, IVT) | Biological: VOY-101<br>* Intravitreal injection of VOY-101<br>|
| Experimental: Mid Dose<br>VOY-101 Mid Dose (single dose, IVT) | Biological: VOY-101<br>* Intravitreal injection of VOY-101<br>|
| Experimental: High Dose<br>VOY-101 High Dose (single dose, IVT) | Biological: VOY-101<br>* Intravitreal injection of VOY-101<br>|
| Active Comparator: Randomized Cohort--MTD<br>VOY-101 MTD (single dose, IVT) | Biological: VOY-101<br>* Intravitreal injection of VOY-101<br>|
| Active Comparator: Randomized Cohort--MTD-1<br>VOY-101 Lower Dose than MTD (single dose, IVT) | Biological: VOY-101<br>* Intravitreal injection of VOY-101<br>|
| Sham Comparator: Randomized Cohort--Sham<br>Control arm (sham procedure) | Biological: VOY-101<br>* Intravitreal injection of VOY-101<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Endpoints | 1. Frequency of ocular and systemic adverse events (AEs) (serious [SAEs] and treatment-emergent non-serious adverse events [TEAEs]) | Through 24 months |