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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05380492
Other study ID # PBI-AMD-001
Secondary ID
Status Active, not recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date November 17, 2022
Est. completion date November 2025

Study information

Verified date April 2024
Source Perceive Biotherapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 45
Est. completion date November 2025
Est. primary completion date November 2025
Accepts healthy volunteers No
Gender All
Age group 50 Years and older
Eligibility 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


Intervention

Biological:
VOY-101
Intravitreal injection of VOY-101

Locations

Country Name City State
United States Retina Consultants of Texas Bellaire Texas
United States Ophthalmic Consultants of Boston Boston Massachusetts
United States University of Utah Salt Lake City Utah

Sponsors (1)

Lead Sponsor Collaborator
Perceive Biotherapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety Endpoints 1. Frequency of ocular and systemic adverse events (AEs) (serious [SAEs] and treatment-emergent non-serious adverse events [TEAEs]) Through 24 months
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