Study of VOY-101 in Patients With Advanced Non-Neovascular Age-Related Macular Degeneration
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: VOY-101.
- Who it may be relevant to
- Registry conditions: Age-Related Macular Degeneration, Geographic Atrophy, Non-neovascular AMD. Basic parameters: from 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Australia, Israel
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Phase 1/2a Dose Escalation Study of VOY-101 in Patients With Advanced Non- Neovascular Age-Related Macular Degeneration
Overview
The Phase 1 safety study of VOY-101 comprises of escalating dose Cohorts, followed by a Phase 2a.
Detailed 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).
Interventions
- Biological VOY-101
VOY-101
Primary outcome measures
- Overall effect of treatment on retinal structural health [Time frame: Week 48]
Secondary outcome measures (4)
- Overall effect of treatment on retinal structural health [Time frame: Weeks 36, 48, and 96]
- Effect of treatment on vision function [Time frame: Change from baseline]
- Incidence of neovascular AMD [Time frame: Baseline to Week 96]
- VOY-101 Safety [Time frame: Baseline to Week 96]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 7 centers
- Retina Macula Institute of AZ — Scottsdale
- The Retina Partners — Encino
- Retinal Consultants Medical Group — Sacramento
- Retina Consultants San Diego — San Diego
- Star Retina — Burleson
- Retina Center of Texas — Southlake
- University of Utah John A. Moran Eye Center — Salt Lake City
Australia · 2 centers
- Sydney Retina Clinic and Day Surgery — Sydney
- Cerulea Clinical Trials — East Melbourne
Israel · 2 centers
- Rambam Medical Center — Haifa
- Tel-Aviv Sourasky Medical Center, Ophthalmology Division — Tel Aviv
Identifiers
NCT: NCT06087458 · PBI-AMD-002