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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Dose | Experimental | VOY-101 Low Dose (single dose, IVT) |
|
| Mid Dose | Experimental | VOY-101 Mid Dose (single dose, IVT) |
|
| High Dose | Experimental | VOY-101 High Dose (single dose, IVT) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VOY-101 | Biological | Intravitreal injection of VOY-101 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety Endpoints | 1. Frequency of ocular and systemic adverse events (AEs) (serious [SAEs] and treatment-emergent non-serious adverse events [TEAEs]) | Through 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ophthalmic Consultants of Boston | Boston | Massachusetts | 02114 | United States | ||
| Retina Consultants of Texas |
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| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D057092 | Geographic Atrophy |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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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.
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The Phase 1 cohorts will be open-label, the Phase 2a cohort will be masked.
| Bellaire |
| Texas |
| 77401 |
| United States |
| University of Utah | Salt Lake City | Utah | 84112 | United States |