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.
NCT Number: NCT06539481
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Non-infectious Uveitis Affecting the Posterior Segment of the Eye
Interventions: DRUG: fluocinolone acetonide 190 micrograms
Sponsor: Alimera Sciences
Sex: ALL
Age: CHILD
Enrollment: 25
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-08-31
Completion Date: 2028-10-31
Locations: Charité - Universitätsmedizin Berlin Institute of Health Department of Ophthalmology, Berlin, Germany|Augenzentrum am St. Franziskus-Hospital Münster, Münster, Germany|Hospital Universitario Cruces, Bilbao, Spain|Fundación Jiménez Díaz, Madrid, Spain|University of Bristol Bristol Medical School, Bristol, United Kingdom|Sheffield Teaching Hospitals NHS Foundation Trust and Sheffield Children NHS Foundation Trust, Sheffield, United Kingdom

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.

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

Primary Outcome Measures: Absence of cystoid macular oedema on Optical Coherence Tomography and a decrease from baseline in vitreous haze grade of ≥2 steps, or absence of vitreous haze., The primary endpoint for evaluating the effect of the implant on non-infectious uveitis affecting the posterior segment of the eye will be based on treatment success, determined at 6 months after administration. Treatment success will be determined based on a composite variable defined as Absence of cystoid macular oedema on Optical Coherence Tomography and a decrease from baseline in vitreous haze grade of ≥2 steps, or absence of vitreous haze., 6 months after administration|Rate of cataract formation and Rate of IOP elevation, The primary endpoint for evaluating the safety of the implant on non-infectious uveitis affecting the posterior segment of the eye will be determined.

* Rate of cataract formation
* Rate of IOP elevation (Change from baseline in IOP and incidence of significant changes in IOP, including: IOP\>21 mmHg, IOP\>25 mmHg, IOP\>30 mmHg, increases from baseline of 10 mmHg or more)., 6 months after administration
Secondary Outcome Measures: Changes in vision and incidence of increase in IOP, AE, and uveitis recurrence, * Absence of CMO and decrease from baseline in vitreous haze grade of ≥2 steps, or absence of vitreous haze at end of the study
* Uveitis recurrence rate following treatment, compared to the uveitis recurrence rate over the 12 months prior to enrolment
* Incidence of recurrence of non-infectious uveitis affecting the posterior segment in the SE and in the FE after receiving study treatment
* Time to recurrence of non-infectious uveitis affecting the posterior segment
* Change in macular oedema,
* Change in BCVA
* Change in vitreous haze
* Change in AC cell grade
* Incidence of secondary increase in IOP and secondary increase in IOP requiring surgical intervention
* Incidence and onset of secondary lens opacity and extraction
* Number of adjunctive treatments required to treat recurrences of uveitis
* Presence of active chorioretinal
* Presence of retinal vascular lesions
* Incidence of ocular infection
* Incidence of AEs
* Change from baseline in cup-to-disc ratio, Every 6 months over 3 years|Incidence of secondary increase in IOP, secondary increase in IOP requiring surgical intervention, and ocular and non-ocular AEs., Mandatory safety measures including IOP checks will be performed every 3 months.

The following secondary safety endpoints will be assessed at 6 months, 12 months or 36 months

* Incidence of secondary increase in IOP
* Incidence of secondary increase in IOP requiring surgical intervention
* Incidence of ocular and non-ocular AEs., 3, 6, 12, and 36 months.