Testing ILUVIEN® for treating recurrent eye inflammation in children and adolescents
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
PHASE4 · ANI Pharmaceuticals · NCT06539481
This study is testing if a new eye implant can help children and teens with recurring eye inflammation feel better and see more clearly.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 6 Years to 17 Years |
| Sex | All |
| Sponsor | ANI Pharmaceuticals (industry) |
| Locations | 6 sites (Berlin and 5 other locations) |
| Trial ID | NCT06539481 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the safety and effectiveness of ILUVIEN® (190μg) in children and adolescents aged 6 to 17 with recurrent non-infectious uveitis affecting the posterior segment of the eye. Participants will receive a single implant that releases a corticosteroid to manage inflammation for up to 36 months. The success of the treatment will be assessed based on the reduction of swelling and cloudiness in the eye after six months. Follow-up assessments will continue for a total of 36 months to monitor the treatment's impact.
Who should consider this trial
Good fit: Ideal candidates are children and adolescents aged 6 to 17 with a history of recurrent non-infectious uveitis that has not been adequately controlled by standard treatments.
Not a fit: Patients with a history of intraocular surgery in the study eye within the last 90 days or those with hypersensitivity to ILUVIEN® components may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve vision and quality of life for young patients suffering from recurrent non-infectious uveitis.
How similar studies have performed: Previous studies have shown promising results with corticosteroid implants for uveitis, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 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
Where this trial is running
Berlin and 5 other locations
- Charité - Universitätsmedizin Berlin Institute of Health Department of Ophthalmology — Berlin, Germany (NOT_YET_RECRUITING)
- Augenzentrum am St. Franziskus-Hospital Münster — Münster, Germany (RECRUITING)
- Hospital Universitario Cruces — Bilbao, Spain (RECRUITING)
- Fundación Jiménez Díaz — Madrid, Spain (RECRUITING)
- University of Bristol Bristol Medical School — Bristol, United Kingdom (RECRUITING)
- Sheffield Teaching Hospitals NHS Foundation Trust and Sheffield Children NHS Foundation Trust — Sheffield, United Kingdom (RECRUITING)
Study contacts
- Study coordinator: Clinical Operations
- Email: clinicaltrials@alimerasciences.com
- Phone: 353 (0) 1 553 0215
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Non-infectious Uveitis Affecting the Posterior Segment of the Eye