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| Name | Class |
|---|---|
| AAVantgarde Bio UK Ltd | UNKNOWN |
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The purpose of the 039-101 study is to evaluate the safety and tolerability of a single subretinal injection of AAVB-039 in participants with Stargardt disease secondary to a biallelic mutation of the ABCA4 gene. The study will also assess initial efficacy following AAVB-039 administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | AAVB-039 dose level 1 (low dose) |
|
| Cohort 2 | Experimental | AAVB-039 dose level 2 (mid dose) |
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| Cohort 3 | Experimental | AAVB-039 dose level 3 (high dose) |
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| Cohorts 4-5 | Experimental | AAVB-039 dose level 1, 2 or 3 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AAVB-039 | Biological | Single subretinal administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| To measure the number and severity of treatment related adverse events following treatment with AAVB-039 | 0-60 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the area of atrophy (assessed via short wavelength fundus autofluorescence (SW-FAF), following treatment with AAVB-039 | 0-60 months | |
| Change in ellipsoid zone (EZ) loss following treatment with AAVB-039 | 0-60 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| AAVantgarde Clinical Operations Lead | Contact | +448000465680 | clinicaltrials@aavantgarde.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Associated Retina Consultants | Recruiting | Phoenix | Arizona | 85020 | United States |
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| ID | Term |
|---|---|
| D000080362 | Stargardt Disease |
| ID | Term |
|---|---|
| D015785 | Eye Diseases, Hereditary |
| D005128 | Eye Diseases |
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
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| Change in macular sensitivity assessed via microperimetry following treatment with AAVB-039 | 0-60 months |
| Change in visual acuity following treatment with AAVB-039 | 0-60 months |
| Retina Vitreous Associates Medical Group | Recruiting | Los Angeles | California | 90211 | United States |
|
| Mayo Clinic | Recruiting | Rochester | Minnesota | 55905 | United States |
|
| Retina Consultants of Texas | Recruiting | Bellaire | Texas | 77401 | United States |
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| Retina Foundation of the Southwest | Recruiting | Dallas | Texas | 75231 | United States |
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| University of Utah | Recruiting | Salt Lake City | Utah | 84112 | United States |
|
| Moorfields Eye Hospital NHS Foundation Trust | Recruiting | London | England | EC1V 2PD | United Kingdom |
| The Retina Clinic | Recruiting | London | England | W1G 9AX | United Kingdom |
| D012164 |
| Retinal Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |