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.

Last updated: August 1, 2024
Sponsor: Alimera Sciences
Overall Status: Active - Recruiting

Phase

4

Condition

Uveitis

Treatment

fluocinolone acetonide 190 micrograms

Clinical Study ID

NCT06539481
ALI-P01-21-006
  • Ages 6-17
  • All Genders

Study 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

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

Total Participants: 25
Treatment Group(s): 1
Primary Treatment: fluocinolone acetonide 190 micrograms
Phase: 4
Study Start date:
August 31, 2024
Estimated Completion Date:
October 31, 2028

Connect with a study center

  • Charité - Universitätsmedizin Berlin Institute of Health Department of Ophthalmology

    Berlin,
    Germany

    Site Not Available

  • Augenzentrum am St. Franziskus-Hospital Münster

    Münster,
    Germany

    Active - Recruiting

  • Hospital Universitario Cruces

    Bilbao,
    Spain

    Active - Recruiting

  • Fundación Jiménez Díaz

    Madrid,
    Spain

    Active - Recruiting

  • University of Bristol Bristol Medical School

    Bristol,
    United Kingdom

    Active - Recruiting

  • Sheffield Teaching Hospitals NHS Foundation Trust and Sheffield Children NHS Foundation Trust

    Sheffield,
    United Kingdom

    Active - Recruiting

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