An Observational Study in Children and Adults With Stargardt Disease
- Conditions
- Stargardt Disease
- Registration Number
- NCT06591806
- Lead Sponsor
- AAVantgarde Bio Srl
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 80
Inclusion Criteria:<br><br> 1. Male and female subjects between 8 and 50 years of age at the time of enrolment.<br><br> 2. Willingness to adhere to the protocol as evidenced by written informed consent if<br> the subject is 18 years or older. If the subject is under 18 years of age, written<br> assent must be obtained from the subject and written informed consent must be<br> obtained from the subject's legally authorized representative (parent or legal<br> guardian).<br><br> 3. Confirmed mutation in the ABCA4 gene.<br><br>Exclusion Criteria:<br><br> 1. History of uveitis.<br><br> 2. Any ocular disease in either eye that may confound assessment of the retina<br> morphologically and functionally.<br><br> 3. Any pathology of the posterior segment other than ABCA4 retinopathy.<br><br> 4. Presence of any other genetic mutation(s) that have been associated with retinal or<br> macular dystrophy.
Not provided
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To measure the change from baseline in Fundus Autofluorescence
- Secondary Outcome Measures
Name Time Method