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

Stargardt Disease

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

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Interventions

Oral Tinlarebant tablet (5mg) once daily for 24 months. Subjects will record the administation of the study drug via daily patient diary.

Locations(1)

Taiwan, Province Of China

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