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.

Официальное название

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

Обзор

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

Вмешательства

• Препарат 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.

Первичные конечные точки

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

Вторичные конечные точки (2)

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

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Германия · 2 центра

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

Испания · 2 центра

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

Великобритания · 2 центра

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

Идентификаторы

NCT: NCT06539481 · ALI-P01-21-006

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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