ActivePhase 2ACTRN12623001328662
An Open-Label, Single-Arm, 2-Year Extension Study to Evaluate Safety and Tolerability of Tinlarebant in Subjects with Stargardt Disease
Sponsor
RBP4 Pty Ltd
Enrollment
12 participants
Start Date
Nov 14, 2023
Study Type
Interventional
Conditions
Summary
Since Tinlarebant has not yet been approved, the purpose of this study is to continuously provide Tinlarebant to patients who have completed the 24 months of treatment with Tinlarebant in the previous study (i.e., LBS-008-CT02) with no safety issues.
Eligibility
Sex: Both males and femalesMin Age: 12 YearssMax Age: 20 Yearss
Inclusion Criteria1
- Subject has completed treatment in LBS-008-CT02 trial and has also completed the tests and assessments required end-of-treatment visit.
Exclusion Criteria3
- Ocular surgery in the study eye in the previous 3 months.
- Use of prescription medications such as Isotretinoin (13-cis-retinoic acid) or other retinol modulators or derivatives
- Use of any known drugs or supplements that are moderate or strong inhibitors/inducers of cytochrome P450 (CYP) enzymes
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Oral Tinlarebant tablet (5mg) once daily for 24 months. Subjects will record the administation of the study drug via daily patient diary.
Oral Tinlarebant tablet (5mg) once daily for 24 months. Subjects will record the administation of the study drug via daily patient diary.
Locations(1)
View Full Details on ANZCTR
For the most up-to-date information, visit the official listing.
ACTRN12623001328662
Related Trials
Oral Metformin for Treatment of ABCA4 Retinopathy
NCT045457362 locations
A Study to Learn How Stargardt-type Eye Conditions Progress in Children and Adults
NCT074255743 locations
Phase 1/2 Open-Label Dose-Escalation Study to Evaluate Safety of a Single Intravitreal Injection of RTx-021 in Patients With Stargardt Disease
NCT074398873 locations
Study of ALK-001 on the Progression of Stargardt Disease
NCT074193341 location
Restoration of Central Vision With PRIMA in Patients With Photoreceptor Degeneration
NCT072665841 location