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

Perceive Biotherapeutics

Status and phase: Active, not recruiting; Phase 2; Phase 1

Conditions: Non-neovascular Age-related Macular Degeneration; Age-Related Macular Degeneration; Geographic Atrophy; Non-neovascular AMD

Treatments: Biological: VOY-101

Study type: Interventional

Funder types: Industry

Identifiers

NCT06087458

PBI-AMD-002

Details and patient eligibility

About

The Phase 1 safety study of VOY-101 is comprised of escalating dose Cohorts, followed by a Phase 2 at the recommended phase 2 dose.

Full description

The study has a prospective, open-label, multi-center, two-part design to evaluate a single, unilateral intravitreal (IVT) injection of VOY-101 in subjects with geographic atrophy (GA), the advanced form of non-neovascular age-related macular degeneration (AMD). Phase 1 followed a standard dose escalation model to establish safety and tolerability of VOY-101 and determine the recommended phase 2 dose. This dose is being used in the randomized Phase 2 part of the study to evaluate the safety and efficacy of VOY-101 in the study eye compared to untreated fellow eye.

Enrollment: 60 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Are ≥60 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 for both eyes.
• Absence of signs of non-exudative MNV.
• Additional Ocular Inclusion Criteria for both eyes.
• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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60 participants in 5 patient groups

Low

Experimental group

Description:

Single, unilateral, intravitreal injection of low dose of VOY-101

Treatment:

Biological: VOY-101

Medium

Experimental group

Description:

Single, unilateral, intravitreal injection of medium dose of VOY-101

Treatment:

Biological: VOY-101

High

Experimental group

Description:

Single, unilateral, intravitreal injection of high dose of VOY-101

Treatment:

Biological: VOY-101

Higher

Experimental group

Description:

Single, unilateral, intravitreal injection of higher dose of VOY-101

Treatment:

Biological: VOY-101

Intermediate

Experimental group

Description:

Single, unilateral, intravitreal injection of intermediate dose of VOY-101

Treatment:

Biological: VOY-101