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Tinlarebant for Stargardt Disease (DRAGON Trial)
Phase 3
Waitlist Available
Research Sponsored by Belite Bio, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subject must have clinically diagnosed STGD1 (Stargardt disease 1) 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline thru month 24
Awards & highlights
DRAGON Trial Summary
This trial is testing a drug to see if it can slow the growth of atrophic lesions in people with STGD1.
Who is the study for?
Adolescents aged 12-20 with Stargardt Disease (STGD1) and a specific gene mutation. They must have certain eye health criteria, like a lesion size within limits and vision of 20/200 or better. Participants need to agree to follow the study rules and provide informed consent.Check my eligibility
What is being tested?
The trial is testing Tinlarebant's effectiveness in slowing down the growth of lesions in the eyes caused by STGD1 compared to a placebo. The main goal is to see if this drug can help preserve vision in affected adolescents.See study design
What are the potential side effects?
While specific side effects for Tinlarebant are not listed here, common side effects for treatments like these may include irritation at the site of administration, potential allergic reactions, headaches, nausea, or visual disturbances.
DRAGON Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have Stargardt disease with a confirmed ABCA4 gene mutation.
Select...
My eye condition has been confirmed with a specific imaging test.
Select...
I have Stargardt disease with a confirmed ABCA4 gene mutation.
Select...
I am between 12 and 20 years old.
Select...
I am between 12 and 18 years old.
Select...
My vision in the study eye is 20/200 or better and I have specific lesion sizes.
DRAGON Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline thru month 24
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline thru month 24
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To measure change in atrophic lesion size (definitely decreased autofluorescence, DDAF) by fundus autofluorescence (FAF) photography from baseline
Secondary outcome measures
The correlation between change in plasma RBP4 level and the rate of lesion size growth (definitely decreased autofluorescence, DDAF) by fundus autofluorescence (FAF) photography from baseline
To assess the systemic and ocular safety and tolerability of tinlarebant
To measure change in BCVA (Best Corrected Visual Acuity) score measured by the EDTRS method from baseline
+3 moreOther outcome measures
To measure change in quantitative autofluorescence (qAF) level from baseline
To measure change in questionably decreased autofluorescence (QDAF) by FAF photography from baseline
To measure change in retinal sensitivity by microperimetry from baseline
+1 moreDRAGON Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: TinlarebantExperimental Treatment1 Intervention
5 mg tablet taken orally once a day
Group II: PlaceboPlacebo Group1 Intervention
Placebo tablets for tinlarebant 5 mg are prepared similarly but use microcrystalline cellulose, NF, in place of the active drug substance and will be identical in size and appearance.
Find a Location
Who is running the clinical trial?
Belite Bio, IncLead Sponsor
5 Previous Clinical Trials
568 Total Patients Enrolled
1 Trials studying Stargardt Disease
13 Patients Enrolled for Stargardt Disease
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have Stargardt disease with a confirmed ABCA4 gene mutation.My eye condition has been confirmed with a specific imaging test.I have Stargardt disease with a confirmed ABCA4 gene mutation.I have no eye conditions other than Stargardt disease that could affect treatment assessment.I have received gene therapy before.I am between 12 and 20 years old.I am between 12 and 18 years old.My vision in the study eye is 20/200 or better and I have specific lesion sizes.I have had eye surgery in the last 3 months.I haven't taken any experimental drugs recently.
Research Study Groups:
This trial has the following groups:- Group 1: Tinlarebant
- Group 2: Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Stargardt Disease Patient Testimony for trial: Trial Name: NCT05244304 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has Tinlarebant been cleared by the FDA?
"There is some clinical data to support the efficacy of Tinlarebant, as well as a robust dataset on its safety. Consequently, we have given it a score of 3."
Answered by AI
Could you provide an estimate for the amount of individuals who have agreed to participate in this clinical trial?
"In order to conduct the study, 60 individuals that fall under the given criteria must be recruited. The trial sponsor, Belite Bio, Inc, will run the study from several locations, such as University of Utah Health in Salt Lake City, Utah and Columbia University Irving Medical Center, Harkness Eye Institute in New york, New York."
Answered by AI
For this particular test, are octogenarians being sought out?
"This particular study is only seeking patients that fall between the ages of 12 to 18. Out of the 11 similar trials, this is the only one that specifically excludes patients under 18 and those over 65."
Answered by AI
Which patients are being recruited for this trial?
"This clinical trial is meant for those who have macular degeneration and are aged 12-18. There are only 60 spots available in the study."
Answered by AI
Who else is applying?
What state do they live in?
Ontario
Florida
Other
California
How old are they?
65+
< 18
18 - 65
What site did they apply to?
Vitreo Retional Surgery PLLC
Stanford Byers Eye Institute
Columbia University Irving Medical Center, Harkness Eye Institute
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
1
0
Why did patients apply to this trial?
I want to find treatment for myself and others. I am eager to be apart of a potential cure for Stargardts.
PatientReceived 2+ prior treatments
I´m a young human and I need my vision for my further life. I want improved vision, but also wan tot make sure my vision doesn't deteriorate any more.
PatientReceived 1 prior treatment
How responsive is this trial?
Typically responds via
Email
Average response time
- < 2 Days
Most responsive sites:
- Stanford Byers Eye Institute: < 48 hours
- Vitreo Retional Surgery PLLC: < 48 hours
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