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