AuthorisedTherapeutic confirmatory (Phase III)Interventional

An Open-Label, Single-Arm, 3-Year Extension Study to Evaluate Safety and Tolerability of Tinlarebant in Subjects with Stargardt Disease

This research is an important follow-up study for people with Stargardt Disease. It focuses on a potential new medicine called tinlarebant, also known as LBS-008. The main goal is to understand if this medicine is safe to use and how well people tolerate it over a longer period, specifically three years. Doctors will take special photographs of the back of the eye, called Fundus Autofluorescence (FAF) photography, to look for any changes in parts of the eye where the cells might be unhealthy. This will help them see if the medicine is having any effect on the progression of the disease. This is a "Phase III" study, meaning it's a key step to confirm the medicine's effects before it can potentially become widely available.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Belite Bio Inc.

Enrolment target

Start

07 Apr 2026

Stargardt Disease

What is this study about?

This clinical trial is designed for people who have Stargardt Disease and are interested in a new treatment called tinlarebant (also known as LBS-008). Stargardt Disease is an inherited eye condition that can cause blurry vision and lead to sight loss over time. Researchers are hoping that tinlarebant might help to slow down or even stop the progression of the disease.

This particular study is a follow-up, called an "extension study," which means it’s for people who might have already taken tinlarebant in an earlier study. The main purpose is to gather more information about the long-term safety of the medicine and how well people's bodies cope with it over three years. It's really important to collect this long-term data to make sure any new medicine is not only effective but also safe for people to use.

To understand if the medicine is working or if any changes are happening in the eyes, doctors will use a special camera to take pictures of the back of the eye. This technique is called Fundus Autofluorescence (FAF) photography. They will carefully look at these pictures to see if there are any areas where the eye cells are becoming less healthy (which they call 'decreased autofluorescence'). By tracking these changes over three years, they can learn more about the medicine's effect on Stargardt Disease.

Key takeaways

It's a study for a new medicine (tinlarebant) for Stargardt Disease.
The study aims to check the medicine's long-term safety and how people tolerate it.
It's a 3-year extension study, likely for previous participants.
Doctors will use special eye photos (FAF) to monitor changes.
It's a 'Phase III' study, a key step before potential wider availability.

Who may be eligible?

To be considered for this study, you must be at least 18 years old. The researchers are looking for both men and women to take part.

It's important to note that this is an 'extension study.' This usually means that participants would have already been involved in an earlier study with the same medicine, tinlarebant (LBS-008).

There might be other specific health requirements or conditions that would determine if you can join, which would be discussed in detail by the study team.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have Stargardt Disease?
Have you previously taken the study medicine, LBS-008 (tinlarebant), in an earlier trial?
Are you able to attend regular clinic visits for 3 years?

Answer every question to see your result.

What does participation involve?

If you join this study, you would primarily be receiving the study medication, tinlarebant (LBS-008), over a three-year period. You would have regular visits to the study clinic where the doctors and nurses would check your general health and, most importantly, your eye health. These visits would involve taking special photographs of your eyes (FAF photography) to see if there are any changes.

The specific number and frequency of visits, as well as the exact tests performed, would be clearly explained to you. You would also have regular follow-up appointments to monitor your progress and ensure your safety throughout the three years.

Potential risks and benefits

Taking part in this study could potentially offer the benefit of receiving a new experimental treatment for Stargardt Disease that isn't yet widely available. While the medicine is being studied to understand its safety and effectiveness, there's no guarantee it will improve your condition. There could be potential risks or side effects from taking the medicine; these would be fully explained to you before you decide to join. It's your right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (3)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Netherlands
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Unverified
France
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Unverified
Belgium

Common questions

What is Stargardt Disease?

Stargardt Disease is an inherited eye condition that causes progressive vision loss, often starting in childhood or adolescence.

What is tinlarebant (LBS-008)?

Tinlarebant is the name of the new medicine being tested in this study for Stargardt Disease.

What does a "Phase III" study mean?

Phase III is a later stage of research where the medicine is given to a larger group of people to confirm its safety and how well it works before it can be considered for general use.

What is FAF photography?

FAF photography is a special way doctors take pictures of the back of your eye to look for changes in the cells, which can help them understand how your eye condition is progressing.

Can anyone join this study?

This study is for adults aged 18 and over, and usually for people who have already participated in an earlier study for LBS-008.