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Study on the Safety and Effectiveness of Fluocinolone Acetonide Implant for Children Aged 6-17 with Recurrent Non-Infectious Uveitis in the Eye's Posterior Segment

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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 non-infectious uveitis, which affects the back part of the eye. This condition can cause inflammation and swelling, leading to vision problems. The study is testing a treatment called ILUVIEN, which is an implant placed inside the eye. The implant contains a small amount of a medication called fluocinolone acetonide, which is designed to help reduce inflammation over a long period.

The purpose of the study is to evaluate the safety and effectiveness of the ILUVIEN implant in children aged 6 to less than 18 years who have recurrent non-infectious uveitis. Participants in the study will receive the implant and be monitored over a period of time to see how well the treatment works and to check for any side effects. The study will look at various outcomes, such as the reduction of swelling in the eye, changes in vision, and the rate of recurrence of the uveitis.

Throughout the study, participants will have regular check-ups to assess their eye health and the effectiveness of the treatment. The study aims to provide valuable information on how well the ILUVIEN implant works in managing non-infectious uveitis in children and to ensure that it is safe for use in this age group. Participants will be closely monitored by healthcare professionals to ensure their safety and well-being during the trial.

The research process

The trial runs in 6 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 patient will be assessed to ensure they meet the eligibility criteria. This includes being between 6 and 18 years old, having a history of recurrent non-infectious uveitis affecting the posterior segment of the eye, and not planning to undergo elective eye surgery during the trial period.
The patient or their legal representative must provide signed informed consent, and the patient must be willing to comply with treatment and follow-up procedures.
Step 2
Initial assessment
An initial assessment will be conducted to evaluate the patient's current eye condition. This includes checking for inflammation, macular edema, and visual acuity using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart.
The patient's medical history will be reviewed to ensure no unstable systemic diseases are present.
Step 3
Treatment administration
The patient will receive an intravitreal implant of ILUVIEN, which contains 190 micrograms of fluocinolone acetonide. This implant is administered directly into the eye to help control inflammation and reduce the recurrence of uveitis.
The implant is designed to release medication over an extended period, reducing the need for frequent treatments.
Step 4
Follow-up visits
Regular follow-up visits will be scheduled to monitor the patient's response to the treatment. These visits will include eye examinations to assess changes in inflammation, macular edema, and visual acuity.
The frequency of these visits will be determined by the study protocol and the patient's individual needs.
Step 5
Monitoring for side effects
Throughout the study, the patient will be monitored for potential side effects, such as increased intraocular pressure (IOP) or cataract formation.
Any adverse events, whether related to the eye or other parts of the body, will be documented and managed according to the study guidelines.
Step 6
Completion of the study
At the end of the study period, a final assessment will be conducted to evaluate the overall effectiveness and safety of the treatment.
The study aims to determine the absence of cystoid macular edema, reduction in vitreous haze, and the rate of uveitis recurrence compared to the period before treatment.

Who can join the trial?

11 criteria

Participants must be boys or girls who are at least 6 years old but younger than 18 years old at the time they agree to join the study.
Participants should not plan to have any optional eye surgery during the study period.
A signed consent form is required from the participant or their legal guardian, and sometimes an additional agreement from the participant, depending on local laws.
The study eye must have a type of eye inflammation called non-infectious posterior, intermediate, or panuveitis, which has come back at least once a year, as determined by the study doctor.
The eye inflammation in the study eye should not be well-controlled by usual treatments due to bad side effects or poor results, according to the study doctor.
Participants must have been treated with systemic corticosteroids (a type of medication) or other similar treatments for at least 3 months in the past year before starting the study.
The study eye must show a certain level of inflammation, such as anterior chamber cells or vitreous haze at Grade 1 or higher, or signs of macular oedema (swelling in the central part of the retina) caused by recurring uveitis.
The study eye must have a visual ability of at least 35 letters on a special eye chart used for testing vision.
Participants should not have any serious health problems that have required changes in their treatment in the 90 days before starting the study.
Participants must be able and willing to follow the treatment plan and attend follow-up visits.
Participants should not expect to move away from the area where the study is being conducted to a place not covered by another study center in the next 36 months.

Who cannot join the trial?

8 criteria

Patients with an eye infection cannot participate.
Patients with a history of severe allergic reactions to the study medication are excluded.
Patients who have had eye surgery within the last 3 months are not eligible.
Patients with uncontrolled high blood pressure are excluded.
Patients with diabetes that is not well-managed cannot participate.
Patients who are pregnant or breastfeeding are not eligible.
Patients who are currently participating in another clinical trial are excluded.
Patients with any other serious health condition that might interfere with the study are not eligible.

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Verified sites

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Charite Universitaetsmedizin Berlin KöR
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Berlin, Germany
Hospital Universitario Fundacion Jimenez Diaz
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Madrid, Spain

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Investigated drugs

ILUVIEN is an implant that is placed inside the eye to help treat inflammation. It is used for children and teenagers who have a condition called non-infectious uveitis, which affects the back part of the eye. The implant slowly releases a small amount of medication over time to reduce swelling and irritation, helping to improve vision and prevent further damage to the eye.

Fluocinolone Acetonide

What is already known about the treatment

Fluocinolone Acetonide – This medication is administered as an intravitreal implant, meaning it is placed directly into the eye. It is currently being studied in a phase IIIb clinical trial to assess its safety and effectiveness in children aged 6 to under 18 years with recurrent non-infectious uveitis affecting the back part of the eye. The main therapeutic use of this medication is to reduce inflammation in the eye. At the molecular level, fluocinolone acetonide works by inhibiting the release of substances in the body that cause inflammation. It is classified as a corticosteroid, which is a type of medication that helps to decrease swelling and irritation.

Investigated diseases

Non-Infectious Uveitis affecting the posterior segment – This is an inflammatory condition that affects the back part of the eye, specifically the retina and choroid. It is not caused by an infection and can lead to symptoms such as blurred vision, floaters, and eye pain. The inflammation can cause complications like cystoid macular edema, which is a swelling of the central retina, and vitreous haze, which is a cloudiness in the gel-like substance inside the eye. Over time, the condition may lead to changes in vision and can cause cataracts or increased intraocular pressure. The disease often follows a pattern of flare-ups and remissions, with periods of active inflammation followed by times of little to no symptoms.