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Tinlarebant for Stargardt Disease (DRAGON II Trial)

Phase 2 & 3
Recruiting
Research Sponsored by Belite Bio, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects must have clinically diagnosed STGD1 with at least one mutation identified in the ABCA4 gene
Subjects must have a defined aggregate atrophic lesion in 1 or both eyes
Must not have
Any prior gene therapy
History of ocular surgery in the study eye in the last 3 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years

Summary

This trial aims to test whether tinlarebant is safe and effective for treating Stargardt Disease.

Who is the study for?
This trial is for individuals with Stargardt Disease, a type of inherited eye disorder that causes vision loss. Participants should have a diagnosis of this condition to be eligible.
What is being tested?
The study is testing the effectiveness and safety of a drug called Tinlarebant compared to a placebo in treating Stargardt Disease. It's designed to see if Tinlarebant can help with symptoms or slow down progression.
What are the potential side effects?
Possible side effects from Tinlarebant are not detailed here, but typically could include reactions at the site of administration, general discomforts like headaches or nausea, and potentially others as observed during the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have Stargardt disease with a confirmed ABCA4 gene mutation.
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I have a specific type of eye damage in one or both eyes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have received gene therapy before.
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I have not had eye surgery in the last 3 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: LBS-008, TinlarebantExperimental Treatment1 Intervention
5 mg tablet taken orally once a day
Group II: PlaceboPlacebo Group1 Intervention
Placebo tablets for tinlarebant 5 mg prepared similarly

Find a Location

Who is running the clinical trial?

Belite Bio, IncLead Sponsor
6 Previous Clinical Trials
672 Total Patients Enrolled
2 Trials studying Stargardt Disease
117 Patients Enrolled for Stargardt Disease
~40 spots leftby Jun 2027
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