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).
Who can participate
Inclusion Criteria:
* Are ≥60 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 for both eyes.
* Absence of signs of non-exudative MNV.
* Additional Ocular Inclusion Criteria for both eyes.
* 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.