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The AAVCAGsCD59 asset has been transferred to Janssen Research and Development LLC
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Patients with advanced dry AMD with GA meeting inclusion criteria will be randomized in one eye in a 1:1:1 ratio comparing intravitreal high or low dose AAVCAGsCD59 with a sham injection. All enrolled subjects will be followed for 24 months to evaluate reduction in GA growth and safety of intravitreal AAVCAGsCD59.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravitreal AAVCAGsCD59 1.071x10e12 vg Injection | Active Comparator | Intravitreal AAVACGsCD59 at a dose of 1.071x10e12 vg administered once on Day 0 |
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| Intravitreal AAVCAGsCD59 3.56x10e11 vg Injection | Active Comparator | Intravitreal AAVACGsCD59 at a dose of 3.56x10e11 vg administered once on Day 0 |
|
| Sham Intravitreal Injection | Sham Comparator | Intravitreal Sham injection administered once on Day 0 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravitreal AAVCAGsCD59 | Biological | AAVCAGsCD59 is administered as an intravitreal injection in the enrolled eye |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the change in Geographic Atrophy area (mm2) measured at Day 0 and compared to the measurement at Month 24 | Geographic atrophy will be measured based on imaging of the retina | 24 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of conversion from dry to wet age-related macular degeneration | Measure the number of treated eyes in the sham and AAVCAGsCD59-treated arms that convert from dry to wet age-related macular degeneration | 24 Months |
| Change in visual acuity of the AAVCAGsCD59 treated eye |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects will be assigned to low dose AAVCAGsCD59, high dose AAVCAGsCD59, or sham arm.
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| Intravitreal Sham Injection | Other | Sham injection mimics a real injection in the enrolled eye |
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Visual acuity measured on an Early Treatment Diabetic Retinopathy Study (ETDRS) chart will be compared at Day 0 and Month 24 |
| 24 Months |
| ID | Term |
|---|---|
| D057092 | Geographic Atrophy |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C005703 | salicylhydroxamic acid |
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