Status:
ACTIVE_NOT_RECRUITING
Study of VOY-101 in Patients With Advanced Non-Neovascular Age-Related Macular Degeneration
Lead Sponsor:
Perceive Biotherapeutics, Inc.
Conditions:
Age-related Macular Degeneration
Geographic Atrophy
Eligibility:
All Genders
50+ years
Phase:
PHASE1
PHASE2
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-st...
Eligibility Criteria
Inclusion
- 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
- Meet certain genotype criteria for risk of AMD.
Exclusion
- 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.
Key Trial Info
Start Date :
November 17 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2025
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT05380492
Start Date
November 17 2022
End Date
November 1 2025
Last Update
April 11 2024
Active Locations (3)
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1
Ophthalmic Consultants of Boston
Boston, Massachusetts, United States, 02114
2
Retina Consultants of Texas
Bellaire, Texas, United States, 77401
3
University of Utah
Salt Lake City, Utah, United States, 84112