Actively 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.
Led by Alimera Sciences · Updated on 2024-08-06
25
Participants Needed
6
Research Sites
217 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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. 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
CONDITIONS
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.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males and females aged 6 to less than 18 years at time of consent
- Non-infectious posterior, intermediate or panuveitis in the study eye with at least 1 recurrence per year
- Uveitis in the study eye not well controlled by standard care due to side effects or poor response
- Treatment with systemic corticosteroid or other systemic therapies for at least 3 months within the past 12 months prior to Day 1
You will not qualify if you...
- Intraocular surgery in the study eye within 90 days before screening
- Hypersensitivity to fluocinolone acetonide or any component of ILUVIEN4
- History of glaucoma or ocular hypertension in the study eye, unless treated with incisional IOP-lowering surgery at least 90 days before screening with stable normal eye pressure
- Increased intraocular pressure greater than 25 mmHg or requiring treatment within 4 weeks before baseline that poses unacceptable risk
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Charité - Universitätsmedizin Berlin Institute of Health Department of Ophthalmology
Berlin, Germany
Not Yet Recruiting
2
Augenzentrum am St. Franziskus-Hospital Münster
Münster, Germany
Actively Recruiting
3
Hospital Universitario Cruces
Bilbao, Spain
Actively Recruiting
4
Fundación Jiménez Díaz
Madrid, Spain
Actively Recruiting
5
University of Bristol Bristol Medical School
Bristol, United Kingdom
Actively Recruiting
6
Sheffield Teaching Hospitals NHS Foundation Trust and Sheffield Children NHS Foundation Trust
Sheffield, United Kingdom
Actively Recruiting
Research Team
C
Clinical Operations
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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