Phase
Condition
Uveitis
Treatment
fluocinolone acetonide 190 micrograms
Clinical Study ID
Ages 6-17 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 historyof recurrence ≥1 per year as assessed by the Investigator
Uveitis in the study eye not adequately controlled by the preferred standard of caredue to intolerable adverse effects or poor response, in the judgment of theInvestigator
Treatment with systemic corticosteroid or other systemic therapies given for atleast 3 months within the previous 12 months prior to Day 1
Exclusion
Exclusion Criteria:
History of intraocular surgery in the study eye within 90 days of the screeningvisit.
Hypersensitivity to FA or any component of ILUVIEN®
History of any form of glaucoma or ocular hypertension in study eye, unless studyeye has been previously treated with an incisional IOP-lowering surgical procedureat least 90 days prior to the screening visit and that procedure has resulted instable IOP in the normal range (10-21 mmHg)
Increased intraocular pressure >25 mmHg or that required treatment includingincreases in medications, surgery (other than drainage surgery), orhospitalisations, within 4 weeks prior to baseline that, in the opinion of theInvestigator, would pose an unacceptable risk to the patient participating in thestudy
Study Design
Connect with a study center
Charité - Universitätsmedizin Berlin Institute of Health Department of Ophthalmology
Berlin,
GermanySite Not Available
Augenzentrum am St. Franziskus-Hospital Münster
Münster,
GermanyActive - Recruiting
Hospital Universitario Cruces
Bilbao,
SpainActive - Recruiting
Fundación Jiménez Díaz
Madrid,
SpainActive - Recruiting
University of Bristol Bristol Medical School
Bristol,
United KingdomActive - Recruiting
Sheffield Teaching Hospitals NHS Foundation Trust and Sheffield Children NHS Foundation Trust
Sheffield,
United KingdomActive - Recruiting
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