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

Phase 2Active Not RecruitingNCT06087458

Perceive Biotherapeutics, Inc.60 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Interventions

VOY-101BIOLOGICAL

VOY-101

Eligibility

Sex: ALLMin age: 60 Years

Medical Language ↔ Plain English

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.

Locations (16)

Retina Macula Institute of AZ

Scottsdale, Arizona, United States

Retina Consultants San Diego

Poway, California, United States

Outcomes

Primary Outcomes

Phase 1: To evaluate the safety and tolerability of a single intravitreal injection of escalating doses of VOY-101

Frequency and type of ocular and systemic adverse events and non-serious treatment-emergent adverse events

Time frame: 24 Months

Phase 1: Change from Baseline in markers of inflammation

Change from Baseline in markers of inflammation including anterior chamber cells, vitreous cells, and retinal vasculitis and retinitis.

Time frame: Baseline to Month 24

Phase 1: Establish the recommended Phase 2 dose in subjects with Geographic Atrophy.

Determine whether the maximum tolerated dose (MTD) has been reached (as determined by the occurrence of dose-limiting toxicities \[DLTs\]) and select the RP2D.

Time frame: Month 12

Phase 2: To evaluate the effect of VOY-101 in the study eye compared with untreated fellow eye on change in Geographic Atrophy lesion size.

Change from Baseline in Geographic Atrophy lesion size

Time frame: 15 Months

Secondary Outcomes

Phase 1: To evaluate the effect of VOY-101 on geographic atrophy lesion size and photoreceptors

Growth rate of total geographic atrophy lesion size and photoreceptor change

Time frame: Baseline through 24 Months

Phase 1/2: To establish the pharmacokinetic (PK) profile of VOY-101.

Change from Baseline for complement levels in aqueous humor

Time frame: Baseline through 24 Months

Phase 1/2: To evaluate the effect of VOY-101 on best corrected distance visual acuity

Data from ClinicalTrials.gov

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