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

Perceive Biotherapeutics

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

Conditions: Geographic Atrophy; Age-related Macular Degeneration

Treatments: Biological: VOY-101

Study type: Interventional

Funder types: Industry

Identifiers

NCT05380492

PBI-AMD-001

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 45 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.
7. Additional Ocular Inclusion Criteria
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.
2. Additional Systemic, Ocular, and Genetic Exclusion Criteria.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

---

45 participants in 3 patient groups

Low Dose

Experimental group

Description:

VOY-101 Low Dose (single dose, IVT)

Treatment:

Biological: VOY-101

Mid Dose

Experimental group

Description:

VOY-101 Mid Dose (single dose, IVT)

Treatment:

Biological: VOY-101

High Dose

Experimental group

Description:

VOY-101 High Dose (single dose, IVT)

Treatment:

Biological: VOY-101