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

Phase 1

Active, not recruiting

• Conditions: Age-related Macular Degeneration; Geographic Atrophy
• Interventions: Biological: VOY-101

• Registration Number: NCT05380492
• Lead Sponsor: Perceive Biotherapeutics, Inc.

Brief Summary

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.

Detailed 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).

Study Timeline

• Study First Submitted: 2022-05-09
• Study First Submitted QC: 2022-05-13
• Study First Posted: 2022-05-19
• Study Start: 2022-11-17
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-10
• Last Update Posted: 2024-04-11
• Primary Completion: 2025-11
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 45

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
High Dose	VOY-101	VOY-101 High Dose (single dose, IVT)
Low Dose	VOY-101	VOY-101 Low Dose (single dose, IVT)
Mid Dose	VOY-101	VOY-101 Mid Dose (single dose, IVT)

Primary Outcome Measures

Name	Time	Method
Safety Endpoints	Through 24 months	1. Frequency of ocular and systemic adverse events (AEs) (serious \[SAEs\] and treatment-emergent non-serious adverse events \[TEAEs\])

Trial Locations

Locations (3)

Retina Consultants of Texas; 🇺🇸 Bellaire, Texas, United States

Ophthalmic Consultants of Boston; 🇺🇸 Boston, Massachusetts, United States

University of Utah; 🇺🇸 Salt Lake City, Utah, United States