Status:
RECRUITING
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.
Lead Sponsor:
Alimera Sciences
Conditions:
Non-infectious Uveitis Affecting the Posterior Segment of the Eye
Eligibility:
All Genders
6-17 years
Phase:
PHASE4
Brief Summary
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. T...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 31 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2028
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT06539481
Start Date
August 31 2024
End Date
October 31 2028
Last Update
August 6 2024
Active Locations (6)
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1
Charité - Universitätsmedizin Berlin Institute of Health Department of Ophthalmology
Berlin, Germany
2
Augenzentrum am St. Franziskus-Hospital Münster
Münster, Germany
3
Hospital Universitario Cruces
Bilbao, Spain
4
Fundación Jiménez Díaz
Madrid, Spain