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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-17

Study Completion Date

2025-11-30

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.

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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).

Conditions

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Age-related Macular Degeneration Geographic Atrophy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

The Phase 1 cohorts will be open-label, the Phase 2a cohort will be masked.

Study Groups

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Low Dose

VOY-101 Low Dose (single dose, IVT)

Group Type EXPERIMENTAL

VOY-101

Intervention Type BIOLOGICAL

Intravitreal injection of VOY-101

Mid Dose

VOY-101 Mid Dose (single dose, IVT)

Group Type EXPERIMENTAL

VOY-101

Intervention Type BIOLOGICAL

Intravitreal injection of VOY-101

High Dose

VOY-101 High Dose (single dose, IVT)

Group Type EXPERIMENTAL

VOY-101

Intervention Type BIOLOGICAL

Intravitreal injection of VOY-101

Interventions

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VOY-101

Intravitreal injection of VOY-101

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

1. Are ≥50 years of age at the time of consent.
2. Are willing and able to understand and provide written informed consent.
3. Are willing and able to return for scheduled treatment and follow-up examinations.
4. Are able to undergo ETDRS BCDVA testing and ophthalmic imaging.
5. Well-demarcated GA secondary to AMD in the absence of MNV and in the absence of history of MNV.
6. Absence of signs of non-exudative MNV.
8. Meet certain genotype criteria for risk of AMD.

Exclusion Criteria

1. 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.

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No