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Taking peoplePhase 4

Fluocinolone acetonide eye implant for children with recurring uveitis

Tests an eye implant in children with recurring non-infectious uveitis.

Key facts

Who runs it
Alimera Sciences
Where
Germany, Spain, and United Kingdom6 sites in 3 countriesChoose a country to see its sites
Trial code
Registry 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.
Status
Recruiting
Phase
Phase 4
People taking part
25 people, planned
Started
31 Aug 2024
Expected to end
31 Oct 2028
Type of study
Interventional
Treatments tested
  • fluocinolone acetonide 190 micrograms
Record updated
6 August 2024

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for children and teenagers with non-infectious uveitis (eye inflammation not caused by an infection) at the back of the eye that keeps coming back. Each person gets one ILUVIEN® implant in the eye.

Age
6 to 17 years (≥6 and <18 years at time of consent)
Sex
Boys and girls can join.
Disease stage
Non-infectious posterior, intermediate or panuveitis in the study eye. It must come back at least 1 time per year. It must not be well controlled by standard care, because of side effects that cannot be tolerated or poor response.
Earlier treatment
Treatment with corticosteroids or other medicines acting on the whole body for at least 3 months within the 12 months before Day 1.

Main reasons for not taking part

  • Eye surgery inside the study eye within 90 days of the screening visit
  • Allergy to FA or any part of ILUVIEN®
  • Any glaucoma or high eye pressure in the study eye, unless treated by surgery at least 90 days before screening with stable pressure of 10-21 mmHg since
  • Eye pressure above 25 mmHg, or eye pressure that needed treatment within 4 weeks before the start, if the doctor judges it too risky

The registry criteria, word for word

Show all 8 criteriaShow less

Who can take part

  • 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 judgment of the Investigator
  • Treatment with systemic corticosteroid or other systemic therapies given for at least 3 months within the previous 12 months prior to Day 1

Who cannot take part

  • History of any form of glaucoma or ocular hypertension in study eye, unless study eye has been previously treated with an incisional IOP-lowering surgical procedure at least 90 days prior to the screening visit and that procedure has resulted in stable IOP in the normal range (10-21 mmHg)
  • Increased intraocular pressure >25 mmHg or that required treatment including increases in medications, surgery (other than drainage surgery), or hospitalisations, within 4 weeks prior to baseline that, in the opinion of the Investigator, would pose an unacceptable risk to the patient participating in the study
  • History of intraocular surgery in the study eye within 90 days of the screening visit
  • Hypersensitivity to FA or any component of ILUVIEN®

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 6 and 17 years old?

This trial has no sites in United States.

It has sites in 3 countries. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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. Treatment success will be measured after 6 months of using the implant.

The treatment will be considered successful if two things happen:

1. No swelling in the back of the eye called cystoid macular oedema; 2. A decrease in the cloudiness inside the eye, called vitreous haze, by at least two levels compared to how it was before the treatment, or the vitreous haze is completely gone.

Participants will:

1. Receive a single treatment with ILUVIEN®, which is a tiny tube that is to be implanted in the eye and releases low levels of the corticosteroid (fluocinolone acetonide) in the eye for up to 36 months. 2. Be followed for 36 months for checkups and tests

The group in the trial

  • ILUVIEN® 190μgTreatment being tested

    Treatment: fluocinolone acetonide 190 micrograms

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Non-randomised, Open-label, Uncontrolled, Multi-centre, Phase IIIb Study Evaluating the Safety and Efficacy of Fluocinolone Acetonide 190 Micrograms Intravitreal Implant in Paediatric Subjects From 6 Years to Less Than 18 Years With Recurrent Non-infectious Uveitis Affecting the Posterior Segment of the Eye
Plain-language title
Fluocinolone acetonide eye implant for children with recurring uveitisGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 15 November 2026.
Fit questions
Built from NCT06539481, who can take part
Record updated
6 August 2024