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Recruiting Phase 1/2 NCT06087458

Study of VOY-101 in Patients With Advanced Non-Neovascular Age-Related Macular Degeneration

Phase 1/2 – combined early trial
Conditions: Age-Related Macular Degeneration Geographic Atrophy Non-neovascular AMD

Sponsor: Perceive Biotherapeutics, Inc.

trial.available_in: БГ
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).
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.
Locations 3
Australia (1)
Sydney Retina Clinic and Day Surgery
Sydney , New South Wales
ACTIVE_NOT_RECRUITING
Israel (1)
Rambam Medical Center
Haifa
United States (1)
Retina Macula Institute of AZ
Scottsdale , Arizona
Technical details
Status
Recruiting
Phase
Phase 1/2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
60 Years
Healthy volunteers
No
Start date
21.06.2023
Completion date
01.03.2028
Registry ID
NCT06087458
Source
anzctr
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