Open for Enrollment Soon
This study will open for enrollment soon. Please contact the study team for more information and check back frequently.
DRAGON (Stargardt Disease) - Clinical Trial
What is the Purpose of this Study?
We are doing this study to find out if an experimental drug called tinlarebant is a safe and effective option for people with Stargardt Disease.
What is the Condition Being Studied?
Stargardt Disease
Who Can Participate in the Study?
Children and adults ages 12-20 who are diagnosed with Stargardt Disease.
For more information, contact the study team at sim15@duke.edu.
Age Group
Adults, Children
What is Involved?
If you choose to join this study, you will get a random assignment (like a coin flip) to either take a 5 mg dose of the study drug or a placebo (inactive substance with no drug in it) every day for 24 months. There is a screening period that lasts about 4 weeks to make sure you are eligible to take part in the study. You will visit our clinic for check-ups about 10 times over the course of the study.
Study Details
Full Title
A Phase 1b Open-laben Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Tinlarebant in Japanese Subjects with Stargardt Disease and a Phase 2/3 Randomized, Double-masked, and Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of Tinlarebant in Subjects with Stargardt Disease - DRAGON - LBS-008-CT07
Principal Investigator
Ophthalmologist
Protocol Number
IRB:
PRO00115629
Phase
Phase
I
Enrollment Status
Open for Enrollment Soon