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

Perceive Biotherapeutics

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Age-Related Macular Degeneration

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 comprises of escalating dose Cohorts, followed by a Phase 2a.

Full description

This is a prospective, open-label, multi-center Phase 1/2a study to evaluate the safety of a single, unilateral intravitreal (IVT) injection of escalating dose levels of VOY-101 therapy in subjects with advanced non-neovascular age-related macular degeneration (AMD).

Enrollment: 140 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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 for study eye.
• 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: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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140 participants in 4 patient groups

Experimental: Low

Experimental group

Description:

Single intravitreal injection of VOY-101

Treatment:

Biological: VOY-101

Experimental: Medium

Experimental group

Description:

Single intravitreal injection of VOY-101

Treatment:

Biological: VOY-101

Experimental: High

Experimental group

Description:

Single intravitreal injection of VOY-101

Treatment:

Biological: VOY-101

Experimental: Higher

Experimental group

Description:

Single intravitreal injection of VOY-101

Treatment:

Biological: VOY-101