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The goal of this study is to evaluate how safe and tolerable KRIYA-825 (VV-14295) is and to determine how effective it is in reducing the growth of geographic atrophy (GA) lesions in the treated eye in patients with GA secondary to age-related macular degeneration (AMD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1a, low dose | Experimental | A single low dose of VV-14295 will be administered on Day 1. In addition, oral prednisone and difluprednate eye drops will be administered prior to and after VV-14295 dosing to reduce the risk of inflammation. After several weeks, participants will switch from difluprednate to prednisolone acetate eye drops. |
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| Part 1a, high dose | Experimental | A single high dose of VV-14295 will be administered on Day 1. In addition, oral prednisone and difluprednate eye drops will be administered prior to and after VV-14295 dosing to reduce the risk of inflammation. After several weeks, participants will switch from difluprednate to prednisolone acetate eye drops. |
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| Part 1b | Experimental | A single dose of VV-14295 determined from Part 1a will be administered on Day 1. In addition, oral prednisone and difluprednate eye drops will be administered prior to and after VV-14295 dosing to reduce the risk of inflammation. After several weeks, participants will switch from difluprednate to prednisolone acetate eye drops. |
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| Part 2 | Experimental | A single dose of VV-14295 determined from Part 1a will be administered on Day 1. In addition, oral prednisone and difluprednate eye drops will be administered prior to and after VV-14295 dosing to reduce the risk of inflammation. After several weeks, participants will switch from difluprednate to prednisolone acetate eye drops. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VV-14295 | Genetic | VV-14295 will be administered as a single suprachoroidal injection. |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of ocular and non-ocular adverse events, abnormal clinical laboratory values, abnormal physical examinations, abnormal vital signs, abnormal electrocardiograms (ECGs), and abnormal ophthalmic findings | Evaluate Part 1 safety of VV-14295 in foveal and non-foveal patients | 12 months |
| Incidence and severity of ocular and non-ocular adverse events, abnormal clinical laboratory values, abnormal physical examinations, abnormal vital signs, abnormal ECGs, and abnormal ophthalmic findings | Evaluate Part 2 safety of VV-14295 in non-foveal GA patients | 12 months |
| Rate of GA progression as assessed by optical coherence tomography (OCT) | Part 2 efficacy of VV-14295 | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of GA progression as assessed by fundus autofluorescence (FAF) | Parts 1 and 2 efficacy of VV-14295 | 3, 6, and 12 months |
| Rate of GA progression as assessed by OCT | Parts 1 and 2 efficacy of VV-14295 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| VP, Medical Affairs | Contact | 984-884-5058 | clinicaltrials@kriyatx.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kriya Clinical Study Site | Recruiting | Ottawa | Ontario | Canada |
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| 3, 6, and 12 months |
| Visual function preservation as assessed by best-corrected visual acuity (BCVA) | Parts 1 and 2 efficacy of VV-14295 | 3, 6, and 12 months |
| Visual function preservation as assessed by low luminance visual acuity (LLVA) | Parts 1 and 2 efficacy of VV-14295 | 3, 6, and 12 months |
| Visual function preservation as assessed by microperimetry | Parts 1 and 2 efficacy of VV-14295 | 3, 6, and 12 months |
| VV-14295 transgene product expression | Concentrations of AAV vector-mediated transgene product in serum | 12 months |
| Immune response to VV-14295 | Humoral and cellular responses to AAV2 capsid and transgene product; anti-AAV2 neutralization capacity in serum | 12 months |
| Vector shedding profile of VV-14295 | Vector shedding in serum, tears, mucus, and urine | 12 months |
| Safety of Everads Injector | Frequency of device-related adverse events and serious adverse events | 1 day post-dose |
| Kriya Clinical Study Site | Recruiting | Tel Aviv | Israel |
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| Kriya Clinical Study Site | Recruiting | Christchurch | New Zealand |