Phase 3, Multicenter, Randomized, Double-Masked, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Tinlarebant in the Treatment of Stargardt Disease in Adolescent Subjects
Who is this study for? Adolescents with Stargardt disease
What treatments are being studied? Tinlarebant
Status: Recruiting
Location: See all (27) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The primary objective of this trial is to assesses the efficacy of tinlarebant in slowing the rate of growth of atrophic lesion(s) in adolescent subjects with STGD1
Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 18
Healthy Volunteers: No
View:
• Male or female subjects 12 to 18 years old, inclusive.
• Subject must have clinically diagnosed STGD1 (Stargardt disease 1) with at least 1 mutation identified in the ABCA4 gene.
• Subject must have a defined aggregate atrophic lesion size within 3 disc areas (7.62 mm2), as imaged by FAF in the study eye Subjects must have a BCVA of 20/200 or better for the study eye based on ETDRS letter score
• Subject and their parent(s) or legal guardian are willing to provide their consent on an Institutional Review Board (IRB)/Independent Ethics Committee (IEC)/Human Research Ethics Committee (HREC)-approved informed consent form (ICF) prior to participating in any study-related procedures.
• Subject agrees to comply with all protocol requirements.
Locations
United States
California
Stanford Byers Eye Institute
Recruiting
Palo Alto
Florida
Vitreoretinal Associates
Not yet recruiting
Gainesville
Minnesota
Vitreo Retional Surgery PLLC
Recruiting
Minneapolis
New York
Columbia University Irving Medical Center, Harkness Eye Institute
Not yet recruiting
New York
Utah
University of Utah Health
Not yet recruiting
Salt Lake City
Other Locations
Australia
Centre For Eye Research Australia Ltd
Recruiting
East Melbourne
Queensland Eye Institute
Recruiting
South Brisbane
Sydney Children's Hospitals Network
Recruiting
Westmead
Belgium
UZ Gent
Not yet recruiting
Gent
UZ Leuven
Not yet recruiting
Leuven
China
Beijing Tongren Hospital - Capital Medical University
Recruiting
Beijing
Beijing Union Medical college Hospital
Recruiting
Beijing
Eye and ENT Hospital of Fudan University
Not yet recruiting
Shanghai
France
Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
Not yet recruiting
Paris
Germany
Universitätsklinikum Bonn
Not yet recruiting
Bonn
Justus-Liebig Universitätklinikum
Recruiting
Gießen
Universitätsklinikum Tübingen
Recruiting
Tübingen
Hong Kong Special Administrative Region
Hong Kong Eye Hospital
Recruiting
Kowloon
Netherlands
Amsterdam University Medical Centers
Not yet recruiting
Amsterdam
Radboud University Medical Centers
Not yet recruiting
Nijmegen
Rotterdam Ophthalmic Institute
Not yet recruiting
Rotterdam
Switzerland
University Hospital Basel, Eye Clinic
Recruiting
Basel
Taiwan
National Taiwan University Hospital
Recruiting
Taipei
Chang Gung Memorial Hospital, Linkou
Recruiting
Taoyuan City
United Kingdom
Moorfields Eye Hospital
Recruiting
London
Manchester Centre for Genomic Medicine
Not yet recruiting
Manchester
Southampton General Hospital
Not yet recruiting
Southampton
Contact Information
Primary
Belitebio - Clinical Trial
clinicaltrial@belitebio.com
+886 972 080 097
Time Frame
Start Date:March 28, 2022
Estimated Completion Date:June 2025
Participants
Target number of participants:60
Treatments
Experimental: Tinlarebant
5 mg tablet taken orally once a day
Placebo Comparator: Placebo
Placebo tablets for tinlarebant 5 mg are prepared similarly but use microcrystalline cellulose, NF, in place of the active drug substance and will be identical in size and appearance.