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This is an observational prescreening study. Individuals who are eligible for prescreening will undergo testing procedures that may be used to determine eligibility in ACDN-01 clinical trials.
The prescreening process will be used to help determine the initial eligibility and interest of potential participants in ACDN-01 clinical trials by conducting assessments of key eligibility criteria before the clinical trial screening procedures are performed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prescreening Group | The prescreening study consists of genetic and visual assessments and will require at least 1 onsite visit. All clinical assessments performed are for the purpose of determining research eligibility for ACDN-01 clinical trials. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prescreening Assessments | Diagnostic Test | Various genetic and visual assessments. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Confirm mutations in the ABCA4 gene | Using a Clinical Laboratory Improved Amendments (CLIA)-certified laboratory. | 12 months |
| Confirm the absence of pathogenic mutations in genes known to cause retinal disease other than ABCA4-related retinopathy | Using a Clinical Laboratory Improved Amendments (CLIA)-certified laboratory. | 12 months |
| Measure BCVA and LLVA | Measure best corrected visual acuity and low luminance visual acuity | 12 months |
| Measure the area of retinal atrophy | Using FAF imaging | 12 months |
| Measure baseline retinal structure | Using OCT (SD-OCT) | 12 months |
| Historical FAF or OCT images | Confirm historical timepoint images | 4 years |
| Historical BCVA/LLVA measurements | Collect past measurements | 4 years |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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Males and females with a diagnosis of ABCA4-related retinopathy will be invited to give informed consent prior to prescreening procedures. After appropriate informed consent/assent has been obtained, potential participants will then undergo the assessments to determine eligibility for ACDN-01 clinical trials.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Associate Director, Clinical Operations | Contact | 207-573-0412 | researchtrials@ascidian-tx.com |
| Name | Affiliation | Role |
|---|---|---|
| Alia Rashid | Ascidian Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of San Francisco | Recruiting | San Francisco | California | 94158 | United States | |
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| Vitreo Retinal Associates |
| Recruiting |
| Gainesville |
| Florida |
| 32607 |
| United States |
| Wilmer Eye Institute at John Hopkins | Recruiting | Baltimore | Maryland | 21218 | United States |
| Massachusetts Eye and Ear | Recruiting | Boston | Massachusetts | 02114 | United States |
| University of Michigan Kellogg Eye Center | Recruiting | Ann Arbor | Michigan | 48105 | United States |
| Cincinnati Eye Institute | Recruiting | Cincinnati | Ohio | 45245 | United States |
| Retina Foundation of Texas | Recruiting | Dallas | Texas | 75382 | United States |
| Retina Consultants of Texas | Recruiting | Houston | Texas | 77401 | United States |
| ID | Term |
|---|---|
| D000080362 | Stargardt Disease |
| D000071700 | Cone-Rod Dystrophies |
| ID | Term |
|---|---|
| D015785 | Eye Diseases, Hereditary |
| D005128 | Eye Diseases |
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D058499 | Retinal Dystrophies |
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