Phase 1/2a Dose Escalation Study of VOY-101 in Patients With Advanced Non- Neovascular Age-Related Macular Degeneration

PBI-AMD-002

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

2023-06-21

2026-10-01

2027-10-01

Recruiting

Early phase I

140

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Phase 1 will enroll in a dose escalation study model, followed by a Phase 2a cohort that will be randomized among two arms.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 140, 'type': 'ESTIMATED'}}

2024-04-23