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Study on Tinlarebant for Treating Geographic Atrophy in Patients

Verified siteInvestigationalNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition called Geographic Atrophy, which is a progressive eye disease that affects the retina, leading to vision loss. The study will evaluate a new treatment called Tinlarebant, also known by its code name LBS-008. This medication is taken in the form of a tablet. The trial will also include a comparison with a placebo, which looks like the Tinlarebant tablet but does not contain the active ingredient.

The purpose of the study is to explore the safety and effectiveness of Tinlarebant in treating Geographic Atrophy. Participants in the study will be randomly assigned to receive either the Tinlarebant tablet or the placebo. The study will last for 24 months, during which participants will have regular check-ups and eye examinations to monitor the size of the affected areas in the retina and assess any changes in vision.

Throughout the study, various tests will be conducted to ensure the safety of the participants and to gather information on how the treatment affects the disease. These tests will include eye exams, blood tests, and other assessments to monitor overall health and any potential side effects. The study aims to provide valuable insights into the potential benefits of Tinlarebant for individuals with Geographic Atrophy.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the participant will be randomly assigned to receive either the active medication, tinlarebant (LBS-008), or a placebo. The placebo is a tablet that looks identical to the active medication but does not contain the active substance.
Step 2
Medication administration
The participant will take the assigned tablet orally. The specific dosage and frequency will be provided by the study team. This will continue for the duration of the study, which is 24 months.
Step 3
Initial assessment
At the beginning of the study, an initial assessment will be conducted. This includes measuring the size of the geographic atrophy lesions in the eyes using a special type of photography called fundus autofluorescence (FAF).
Step 4
Regular follow-up visits
Throughout the 24-month study period, regular follow-up visits will be scheduled. During these visits, various tests and assessments will be conducted to monitor the participant's condition and the effects of the medication. These include eye examinations, blood tests, and other safety assessments.
Step 5
Final assessment
At the end of the 24-month period, a final assessment will be conducted. This will involve measuring the change in the size of the geographic atrophy lesions and other eye health indicators.

Who can join the trial?

8 criteria

Subjects must be willing and able to provide signed informed consent before participating in any study-related procedures. This means they agree to join the study and understand what it involves.
Participants can be male or female and must be between 60 to 85 years old.
Subjects must have a confirmed diagnosis of Geographic Atrophy (GA), which is a condition affecting the eyes. They should have atrophic lesions, which are areas of damage, in one or both eyes. These lesions should measure between 0.5 to 10 square millimeters in total area, as checked by a special eye photograph called fundus autofluorescence (FAF).
If the lesions involve the fovea (the central part of the retina responsible for sharp vision), the vision in the study eye should be 20/80 or better. This means they can read at least 54 letters on a specific eye chart called the ETDRS chart.
If the lesions do not involve the fovea, the vision in the study eye should be 20/100 or better, meaning they can read at least 49 letters on the ETDRS chart.
There is no minimum vision requirement for the other eye.
The study eye must be able to be examined properly at the start of the study. This means the eye should be clear enough for good quality imaging, and the participant should be able to cooperate for eye tests.
Female participants must not be pregnant or breastfeeding. Male participants with partners who can become pregnant, and women who can become pregnant, must use highly effective birth control methods during the study. They should not donate sperm or eggs from the time they agree to join the study until a certain period after the last dose of the study treatment if they stop early.

Who cannot join the trial?

7 criteria

Patients who have any other eye disease that could affect the study results.
Patients who have had eye surgery in the past three months.
Patients who are currently participating in another clinical trial.
Patients who have a history of severe allergic reactions to medications.
Patients who are pregnant or breastfeeding.
Patients who have a serious illness that could interfere with the study.
Patients who are unable to follow the study procedures or attend study visits.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

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Axon Clinical s.r.o.
Prague, Czechia
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CHU Croix Rousse-Lyon
Lyon, France
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Centre Hospitalier Universitaire De Dijon
Dijon, France

Trial locations

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Investigated drugs

Tinlarebant is being studied to see if it can help slow down the growth of geographic atrophy, which is a condition that affects the eyes. The trial is looking at how safe and effective this medication is for people with this condition.

Tinlarebant

What is already known about the treatment

Tinlarebant – Tinlarebant is administered orally in the form of tablets. It is currently being studied in clinical trials, specifically in a Phase 3 study, to evaluate its safety and effectiveness in treating geographic atrophy, a condition that affects the eyes. The main therapeutic indication for Tinlarebant is to slow the progression of geographic atrophy by reducing the growth rate of lesions in the retina. At the molecular level, Tinlarebant works by inhibiting specific pathways that contribute to the degeneration of retinal cells. It is classified pharmacologically as a retinal protective agent.

Investigated diseases

Geographic Atrophy – Geographic Atrophy is a progressive eye disease that affects the macula, the central part of the retina responsible for sharp vision. It is characterized by the gradual degeneration of retinal cells, leading to the formation of atrophic lesions. These lesions expand over time, causing a gradual loss of central vision. The disease typically progresses slowly, and patients may initially notice difficulty reading or recognizing faces. As the condition advances, the affected area of the retina enlarges, further impairing vision. Geographic Atrophy is often associated with age-related macular degeneration, a common cause of vision loss in older adults.