Status:
RECRUITING
An Observational Study in Children and Adults With Stargardt Disease
Lead Sponsor:
AAVantgarde Bio Srl
Conditions:
Stargardt Disease
Eligibility:
All Genders
8-50 years
Brief Summary
This multicenter, prospective, longitudinal, observational study in approximately 80 subjects with Stargardt disease secondary to biallelic mutations in the ABCA4 gene (STGD1) aims to evaluate prognos...
Eligibility Criteria
Inclusion
- Male and female subjects between 8 and 50 years of age at the time of enrolment.
- Willingness to adhere to the protocol as evidenced by written informed consent if the subject is 18 years or older. If the subject is under 18 years of age, written assent must be obtained from the subject and written informed consent must be obtained from the subject's legally authorized representative (parent or legal guardian).
- Confirmed mutation in the ABCA4 gene.
Exclusion
- History of uveitis.
- Any ocular disease in either eye that may confound assessment of the retina morphologically and functionally.
- Any pathology of the posterior segment other than ABCA4 retinopathy.
- Presence of any other genetic mutation(s) that have been associated with retinal or macular dystrophy.
Key Trial Info
Start Date :
May 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 30 2027
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06591806
Start Date
May 1 2024
End Date
June 30 2027
Last Update
August 28 2025
Active Locations (2)
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1
Retina Foundation of the Southwest
Dallas, Texas, United States, 75231
2
Oslo University hospital Ullevål
Oslo, Norway, 0450