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.

Official title

A Non-randomised, Open-label, Uncontrolled, Multi-centre, Phase IIIb Study Evaluating the Safety and Efficacy of Fluocinolone Acetonide 190 Micrograms Intravitreal Implant in Paediatric Subjects From 6 Years to Less Than 18 Years With Recurrent Non-infectious Uveitis Affecting the Posterior Segment of the Eye

Overview

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

Interventions

• Drug fluocinolone acetonide 190 micrograms
  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.

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. [Time frame: 6 months after administration]
• Rate of cataract formation and Rate of IOP elevation [Time frame: 6 months after administration]

Secondary outcome measures (2)

• Changes in vision and incidence of increase in IOP, AE, and uveitis recurrence [Time frame: 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. [Time frame: 3, 6, 12, and 36 months.]

Eligibility criteria

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 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

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Prevention

Study locations

Germany · 2 centers

• Charité - Universitätsmedizin Berlin Institute of Health Department of Ophthalmology — Berlin
• Augenzentrum am St. Franziskus-Hospital Münster — Münster

Spain · 2 centers

• Hospital Universitario Cruces — Bilbao
• Fundación Jiménez Díaz — Madrid

United Kingdom · 2 centers

• University of Bristol Bristol Medical School — Bristol
• Sheffield Teaching Hospitals NHS Foundation Trust and Sheffield Children NHS Foundation Tr — Sheffield

Identifiers

NCT: NCT06539481 · ALI-P01-21-006

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗