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Tests treatment safety and results for Non-infectious Uveitis Affecting the Posterior Segment...
Official title 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.
ClinicalTrials.gov ID: NCT06539481
What this study is testing
What is fluocinolone acetonide 190 micrograms?
fluocinolone acetonide 190 micrograms is an investigational medicine, being studied as a potential treatment for non-infectious uveitis affecting the posterior segment of the eye.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The main aim is to test how safe and effective the medicine ILUVIEN® (190μg) is for children and adolescents, who have non-infectious uveitis that keeps coming back and affects the back of the eye. The main thing Alimera wants to find out is how well the implant works for treating non-infectious uveitis in the back of the eye.
- Phase 4: studies an already-approved treatment
- Time commitment: about 36 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 17
You may be able to join if
- Males and females of ≥6 and \<18 years of age at time of consent
- Non-infectious posterior, intermediate or panuveitis in the study eye with a history of recurrence ≥1 per year as assessed by the Investigator
- Uveitis in the study eye not adequately controlled by the preferred standard of care due to intolerable adverse effects or poor response, in the...
- Treatment with systemic corticosteroid or other systemic therapies given for at least 3 months within the previous 12 months prior to Day 1
You likely can't join if
- History of intraocular surgery in the study eye within 90 days of the screening visit.
- Hypersensitivity to FA or any component of ILUVIEN®
- History of any form of glaucoma or ocular hypertension in study eye, unless study eye has been previously treated with an incisional IOP-lowering...
- Increased intraocular pressure \>25 mmHg or that required treatment including increases in medications, surgery (other than drainage surgery), or...
The study team makes the final eligibility decision.
Where it's taking place
- Berlin, Germany
- Münster, Germany
- Bilbao, Spain
- Madrid, Spain
- Bristol, United Kingdom
- Sheffield, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 36 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 6 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Berlin, Germany; Münster, Germany; Bilbao, Spain; Madrid, Spain; Bristol, United Kingdom; Sheffield, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.