RecruitingPHASE4INTERVENTIONAL

Open Label Trial Studying the Safety and Effectiveness of ILUVIEN® (190μg) in Children and Adolescents, Who Have Recurrent Non-infectious Uveitis Affecting the Posterior Segment of the Eye.

We are conducting a study to learn more about a treatment called ILUVIEN® for children and teenagers between 6 and 17 years old. This treatment is for 'uveitis' which is a type of swelling inside the eye that keeps coming back and affects the back part of the eye. ILUVIEN® is a tiny implant that slowly releases medicine. We want to find out how safe and effective it is at reducing the swelling and improving vision. The study will check if key signs of swelling decrease or go away after 6 months. Participants will receive the implant and have check-ups for about three years to see how they are doing and if the treatment works well long-term.

At a glance

Status

Recruiting

Phase

PHASE4

Sponsor

Alimera Sciences

Enrolment target

Start

31 Aug 2024

Estimated completion

31 Oct 2028

Non-infectious Uveitis Affecting the Posterior Segment of the Eye

What is this study about?

This study is for children and teenagers aged 6 to 17 who have a persistent eye condition called non-infectious uveitis. Uveitis is when the middle layer of your eye, called the uvea, becomes inflamed or swollen. In this specific study, we're looking at uveitis that affects the back part of the eye, keeps returning, and isn't caused by an infection. This kind of swelling can lead to problems with vision.

The main goal of this study is to see how safe and effective a new treatment called ILUVIEN® is for these young people. ILUVIEN® is a tiny tube, like a grain of rice, that is gently placed inside the eye. It slowly releases a small amount of medicine (a type of steroid) over a long time, up to three years. The hope is that this continuous release of medicine will help reduce the inflammation and improve the eye condition more consistently than other treatments.

We will measure how well the treatment works after six months. We'll be looking for two main things: whether a specific type of swelling in the back of the eye, called cystoid macular oedema, has gone away, and if the cloudiness inside the eye, known as vitreous haze, has significantly improved or disappeared. Understanding how this treatment performs in younger people is important because it could offer a new way to manage their eye condition.

Key takeaways

This study is testing a new eye implant for recurring uveitis in young people.
The implant, ILUVIEN®, slowly releases medicine to reduce eye swelling.
Participants must be between 6 and 17 years old with specific type of non-infectious uveitis.
The study will check safety and effectiveness over a 3-year period.
The goal is to find a better way to control eye inflammation and improve vision.

Who may be eligible?

This study is specifically designed for children and teenagers who are at least 6 years old but younger than 18. They must have a diagnosis of non-infectious uveitis that affects the back, middle, or all parts of the eye and has come back at least once a year. Importantly, their current treatments for uveitis either haven't worked well enough or have caused side effects that are too difficult to manage.

There are also some reasons why someone might not be able to join the study. For example, if they've had eye surgery in the past three months in the eye being studied, or if they are allergic to any part of the ILUVIEN® medicine. Anyone who has had certain types of glaucoma or high pressure in their eye, unless it has been successfully treated and stable for a while, might not be able to participate.

The research team will carefully review each potential participant's medical history to make sure the study is a good fit and safe for them. They will check all these details to ensure that only those who meet the specific criteria can take part.

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 between 6 and 17 years old?
Do you have a type of eye inflammation called non-infectious uveitis that affects the back of your eye?
Does your uveitis come back often, and your current treatments haven't worked well or caused difficult side effects?
Have you not had eye surgery in this eye in the past three months?
Do you not have certain types of uncontrolled high eye pressure (glaucoma) in the study eye?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive a single treatment with ILUVIEN®. This involves a tiny implant being placed in your eye during a procedure. This implant will then slowly release medicine into your eye for up to three years.

Following the treatment, you will need to attend regular check-ups and tests at the clinic. These appointments will happen over a period of 36 months (about three years) to monitor your eye health, measure the effects of the treatment, and ensure your safety. The doctors will be looking closely at how the medicine is working and how your eye condition is managed.

Throughout these 36 months, the study team will be checking for signs of swelling and cloudiness in your eye, as well as any side effects. The total duration of your participation in the study, including the treatment and all follow-up visits, will be approximately three years.

Potential risks and benefits

Taking part in a study like this might offer some potential benefits, such as receiving a new treatment that could help manage your uveitis more effectively and reduce frequent flare-ups. This implant is designed to deliver medicine steadily, which might be more convenient than other treatments. However, there are also potential risks involved, as with any medical procedure. These could include risks associated with the eye implant procedure itself, or side effects from the medication. The study team will explain all known side effects. It's important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care. Your safety and well-being are the top priority.

Locations (6)

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

Charité - Universitätsmedizin Berlin Institute of Health Department of Ophthalmology
Verified postcode
Berlin, Germany· Not yet recruiting
Augenzentrum am St. Franziskus-Hospital Münster
Verified postcode
Münster, Germany· Recruiting
Hospital Universitario Cruces
Verified postcode
Bilbao, Spain· Recruiting
Fundación Jiménez Díaz
Verified postcode
Madrid, Spain· Recruiting
University of Bristol Bristol Medical School
Verified postcode
Bristol, United Kingdom· Recruiting
Sheffield Teaching Hospitals NHS Foundation Trust and Sheffield Children NHS Foundation Trust
Verified postcode
Sheffield, United Kingdom· Recruiting

Common questions

What is uveitis?

Uveitis is when the middle layer of your eye, called the uvea, becomes inflamed or swollen. It can cause redness, pain, and blurry vision.

What is ILUVIEN®?

ILUVIEN® is a very small, long-lasting implant that is placed inside the eye. It slowly releases medicine over a long time to help reduce swelling.

Who can join this study?

This study is for children and teenagers aged 6 to 17 who have a specific type of uveitis that keeps coming back and hasn't been well-controlled by other treatments.

How long will I be in the study?

If you join, you'll receive the eye implant and then have check-ups and tests for about three years (36 months).

Will I have to have surgery?

The ILUVIEN® implant is placed in the eye through a minor procedure, similar to an injection, rather than traditional major surgery. The doctors will explain this to you in detail.

How to find out more

Clinical Operations

clinicaltrials@alimerasciences.com 353 (0) 1 553 0215 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.