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.

NCT06539481 | Recruiting Phase 4

• 1 other identifier: ALI-P01-21-006
• Study Type: interventional
• Target: 25
• Locations: 3 countries
• Sites: 6

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. 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. 1.No swelling in the back of the eye called cystoid macular oedema;
2. 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.
3. 3.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.
4. 4.Be followed for 36 months for checkups and tests

Conditions

Non-infectious Uveitis Affecting the Posterior Segment of the Eye

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Changes in vision and incidence of increase in IOP, AE, and uveitis recurrence

  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.

  3, 6, 12, and 36 months.

Study Arms (1)

ILUVIEN® 190μg

EXPERIMENTAL

Drug: fluocinolone acetonide 190 micrograms

Interventions

fluocinolone acetonide 190 micrograms DRUG

ILUVIEN®, is a tiny tube that is to be implanted in the eye and releases low levels of the corticosteroid (fluocinolone acetonide) in the eye. ILUVIEN® delivers corticosteroid directly to the intended site of action for up to 36 months.

ILUVIEN® 190μg

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alimera Sciences: lead

Study Sites (6)

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

Central Study Contacts

Clinical Operations

CONTACT

353 (0) 1 553 0215; clinicaltrials@alimerasciences.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2024
• First Posted: August 6, 2024
• Study Start: August 31, 2024
• Primary Completion (Estimated): July 15, 2026
• Study Completion (Estimated): October 31, 2028
• Last Updated: August 6, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2); ES (2); DE (2)