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Phase 3 Study of Tinlarebant in the Treatment in Adolescent Stargardt Subjects
EU CTIS ID: 2024-513483-26-00
What this study is testing
To assess the efficacy of Tinlarebant in slowing the growth of atrophic lesion(s) in overall adolescent STGD1 subjects
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Male or female subjects 12 to 20 years old, inclusive.
- Subject must have clinically diagnosed STGD1 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. For the complete list, please refer to protocol.
You likely can't join if
- Any ocular disease other than STGD1 at screening that, in the opinion of the investigator, would complicate assessment of a treatment effect.
- History of ocular surgery in the study eye in the last 3 months.
- Investigational drug use of any kind in the last 3 months or within 5 half-lives of the investigational drug, whichever is shorter.
- Any prior gene therapy.
- Vitamin A deficiency as defined based upon plasma values less than 20 μg/dL (=0.7 μmol/L). For the complete list, please refer to protocol.
The study team makes the final eligibility decision.
Where it's taking place
- Hong Kong
- Switzerland
- Korea, Republic of
- United Kingdom
- Australia
- China
- Taiwan
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hong Kong; Switzerland; Korea, Republic of; United Kingdom; Australia; China and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.