Age-related Macular Degeneration, Geographic Atrophy
Conditions
Brief summary
This safety study comprises a dose escalation study of VOY-101, followed by a cohort of subjects randomized to the maximum tolerated dose arm, a lower dose arm, and control arm.
Detailed description
This is a prospective, multi-center safety phase 1/2a study to evaluate the safety of a single, unilateral intravitreal (IVT) injection of three dose levels of VOY-101 therapy in subjects with late-stage non-neovascular age-related macular degeneration (AMD).
Interventions
BIOLOGICALVOY-101
Intravitreal injection of VOY-101
Sponsors
Perceive Biotherapeutics, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The Phase 1 cohorts will be open-label, the Phase 2a cohort will be masked.
Intervention model description
The Phase 1 will enroll in a dose escalation study model (three sequential cohorts), followed by a Phase 2a cohort that will be randomized among a maximum tolerated dose arm, a lower dose arm, and a control arm.
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Are ≥50 years of age at the time of consent. 2. Are willing and able to understand and provide written informed consent. 3. Are willing and able to return for scheduled treatment and follow-up examinations. 4. Are able to undergo ETDRS BCDVA testing and ophthalmic imaging. 5. Well-demarcated GA secondary to AMD in the absence of MNV and in the absence of history of MNV. 6. Absence of signs of non-exudative MNV. 7. Additional Ocular Inclusion Criteria 8. Meet certain genotype criteria for risk of AMD.
Exclusion criteria
1. 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. 2. Additional Systemic, Ocular, and Genetic
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety Endpoints | Through 24 months | 1\. Frequency of ocular and systemic adverse events (AEs) (serious \[SAEs\] and treatment-emergent non-serious adverse events \[TEAEs\]) |
Countries
United States
Outcome results
None listed