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New hope for rare eye disease: drug trial targets vision loss

NCT ID NCT06388083

Disease control Sponsor: Belite Bio, Inc Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a drug called tinlarebant in 60 people with Stargardt disease, a genetic condition that causes vision loss. The goal is to see if the drug can slow damage to the retina and preserve eyesight. Participants take the drug or a placebo, and researchers measure changes in eye health over time.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2024

Expected to finish

Feb 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 to 20 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. * Minimum BCVA is required in the study eye Exclusion Criteria: * Any ocular disease other than STGD1 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. * Any prior gene therapy.

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Conditions

The condition(s) this trial relates to.

severe early-childhood-onset retinal dystrophy Stargardt disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Stargardt disease 1 STGD1

Contacts and locations

Locations

  • Belite Study Site

    Kobe, Japan

  • Belite Study Site

    Kyoto, Japan

  • Belite Study Site

    Tokyo, Japan

  • Belite Study Site - US01

    Boston, Massachusetts, 02115, United States

  • Belite Study Site - US02

    Durham, North Carolina, 27705, United States

  • Belite Study Site - US03

    Dallas, Texas, 75231, United States

  • Belite Study Site - US04

    Rochester, Minnesota, 55905, United States

  • Belite Study Site - US05

    La Jolla, California, 92093, United States

  • Belite Study Site - US06

    Miami, Florida, 33136, United States

  • Belite Study Site - US07

    Philadelphia, Pennsylvania, 19107, United States

  • Belite Study Site - US08

    Phoenix, Arizona, 85020, United States

  • Belite Study Site - US09

    San Francisco, California, 94158, United States

  • Belite Study Site - US10

    Westbury, New York, 11590, United States

  • Belite Study Site - US11

    Edina, Minnesota, 55435, United States

  • Belite Study Site - US12

    The Woodlands, Texas, 77384, United States

  • Belite Study Site - US13

    Austin, Texas, 78705, United States

  • Belite Study Site - US14

    New York, New York, 10032, United States

  • UK01 Belite Study Site

    London, United Kingdom

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