Status:
COMPLETED
This is a Dose-finding Study Followed by 2-year Extension Study to Evaluate Safety and Tolerability of Tinlarebant in Adolescent Subjects With Stargardt Disease
Lead Sponsor:
RBP4 Pty Ltd
Collaborating Sponsors:
Belite Bio, Inc
Conditions:
Stargardt Disease
Eligibility:
All Genders
12-18 years
Phase:
PHASE1
PHASE2
Brief Summary
Stargardt disease 1 (STGD1) is the most prevalent form of juvenile macular degeneration. It is caused by a rare, inherited autosomal recessive trait, leading to severe and irreversible blindness by th...
Eligibility Criteria
Inclusion
- Major
- Subject must have clinically diagnosed Stargardt disease with at least one mutation identified in the ABCA4 gene.
- Major
Exclusion
- Any ocular disease other than Stargardt disease at baseline that, in the opinion of the PI, would complicate assessment of a treatment effect.
Key Trial Info
Start Date :
March 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 15 2023
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT05266014
Start Date
March 12 2021
End Date
August 15 2023
Last Update
April 12 2024
Active Locations (3)
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1
Sydney Children's Hospitals Network
Westmead, New South Wales, Australia, 2145
2
Lions Eye Institute
Perth, Western Australia, Australia, 6009
3
National Taiwan University Hospital
Taipei, Taiwan, 100