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

NCT05380492 | Active Not Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: PBI-AMD-001
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 3

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.

Conditions

Age-related Macular Degeneration; Geographic Atrophy

Outcome Measures

Primary Outcomes (1)

• Safety Endpoints

  1\. Frequency of ocular and systemic adverse events (AEs) (serious \[SAEs\] and treatment-emergent non-serious adverse events \[TEAEs\])

  Through 24 months

Study Arms (3)

Low Dose

EXPERIMENTAL

VOY-101 Low Dose (single dose, IVT)

Biological: VOY-101

Mid Dose

EXPERIMENTAL

VOY-101 Mid Dose (single dose, IVT)

Biological: VOY-101

High Dose

EXPERIMENTAL

VOY-101 High Dose (single dose, IVT)

Biological: VOY-101

Interventions

VOY-101 BIOLOGICAL

Intravitreal injection of VOY-101

High Dose; Low Dose; Mid Dose

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Meet certain genotype criteria for risk of AMD.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Perceive Biotherapeutics, Inc.: lead

Study Sites (3)

Ophthalmic Consultants of Boston

Boston, Massachusetts, 02114, United States

Location

Retina Consultants of Texas

Bellaire, Texas, 77401, United States

Location

University of Utah

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Macular Degeneration; Geographic Atrophy

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The Phase 1 cohorts will be open-label, the Phase 2a cohort will be masked.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The Phase 1 will enroll in a dose escalation study model (three sequential cohorts), followed by a Phase 2a cohort that will be randomized among a maximum tolerated dose arm, a lower dose arm, and a control arm.

Study Record Dates

• First Submitted: May 9, 2022
• First Posted: May 19, 2022
• Study Start: November 17, 2022
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: April 11, 2024

Record last verified: 2024-04

Locations

US (3)