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

Phase 1

Recruiting

• Conditions: Age-Related Macular Degeneration
• Interventions: Biological: VOY-101

• Registration Number: NCT06087458
• Lead Sponsor: Perceive Biotherapeutics, Inc.

Brief Summary

The Phase 1 safety study of VOY-101 comprises of escalating dose Cohorts, followed by a Phase 2a.

Detailed 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).

Study Timeline

• Study Start: 2023-06-21
• Study First Submitted: 2023-10-12
• Study First Submitted QC: 2023-10-12
• Study First Posted: 2023-10-17
• Status Verified: 2024-04
• Last Update Submitted: 2024-11-06
• Last Update Posted: 2024-11-08
• Primary Completion: 2026-10
• Study Completion: 2027-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 140

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Experimental: Low	VOY-101	Single intravitreal injection of VOY-101
Experimental: Medium	VOY-101	Single intravitreal injection of VOY-101
Experimental: High	VOY-101	Single intravitreal injection of VOY-101
Experimental: Higher	VOY-101	Single intravitreal injection of VOY-101

Primary Outcome Measures

Name	Time	Method
Safety and Tolerability as measured by frequency of ocular and systemic adverse events (AEs) (serious [SAEs] and treatment-emergent non-serious adverse events [TEAEs])	24 months

Trial Locations

Locations (5)

Cerulea Clinical Trials; 🇦🇺 East Melbourne, Victoria, Australia

Rambam Medical Center; 🇮🇱 Haifa, Israel

Sydney Retina Clinic and Day Surgery; 🇦🇺 Sydney, New South Wales, Australia

Cabrini Research; 🇦🇺 Melbourne, Victoria, Australia

Tel-Aviv Sourasky Medical Center, Ophthalmology Division; 🇮🇱 Tel Aviv, Israel