Набор скоро начнётся NCT07423442

Frequency and Intensity of Inflammatory Relapses in Patients With Non-infectious Posterior Uveitis Treated With a Fluocinolone Acetonide Implant

— Наблюдательное Noninfectious Posterior Uveitis Uveitis, Posterior Uveitic Macular Edema

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: fluocinolone acetonide intravitreal implant.
Кому может быть актуально: Состояния в реестре: Noninfectious Posterior Uveitis, Uveitis, Posterior, Uveitic Macular Edema. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Франция
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Frequency and Intensity of REcurrences in Non-infectious Posterior Uveitis Treated With Fluocinolone Acetonide Implant (FACi): a Multicenter Retrospective Real-world Study

Обзор

Non-infectious posterior uveitis is a chronic inflammatory eye disease that can lead to irreversible retinal damage and visual impairment due to repeated inflammatory relapses. The fluocinolone acetonide intravitreal implant is approved for the prevention of inflammatory relapses in this condition, but data from real-world clinical practice remain limited, particularly regarding the intensity of relapses over time. This multicenter retrospective observational study aims to evaluate the frequency and intensity of inflammatory recurrences in adult patients with non-infectious posterior uveitis treated with a fluocinolone acetonide implant. Clinical and imaging data routinely collected during follow-up will be analyzed over a three-year period to better characterize long-term outcomes, treatment burden, and safety in real-life conditions.

Подробное описание

This is a multicenter, retrospective, real-world observational study conducted in ophthalmology departments of several French university and general hospitals.

The study includes adult patients with non-infectious posterior uveitis or persistent posterior segment inflammation who received a fluocinolone acetonide intravitreal implant as part of routine clinical care. All treatments were prescribed independently of the study, and no intervention was assigned by the investigators.

Data are collected retrospectively from medical records and include clinical, functional, and imaging parameters routinely used in uveitis follow-up. The primary objective is to assess the intensity of inflammatory relapses before and after implantation by analyzing variations in best corrected visual acuity, central macular thickness, and laser flare measurements over predefined time periods.

Secondary objectives include evaluation of relapse frequency, retreatment burden, changes in systemic anti-inflammatory or immunosuppressive therapies, identification of predictive factors associated with relapse severity, and assessment of the long-term safety profile of the fluocinolone acetonide implant in real-life practice.

Data are pseudonymized and recorded in a secure electronic database hosted by the sponsor institution, in compliance with applicable data protection regulations. Analyses are primarily descriptive, reflecting the observational nature of the study.

This study is conducted in accordance with French regulations for non-interventional research and aims to provide complementary real-world evidence to existing clinical trial data on the long-term management of non-infectious posterior uveitis.

Вмешательства

Препарат fluocinolone acetonide intravitreal implant
Intravitreal corticosteroid implant delivering fluocinolone acetonide, administered as part of routine clinical management for the prevention of inflammatory relapses and macular edema in non-infectious posterior uveitis. Treatment decisions were made independently of the study.

Первичные конечные точки

Intensity of inflammatory recurrences after fluocinolone acetonide implant [Срок оценки: Year -1 before implantation 0 to 12 months after implantation 12 to 24 months after implantation 24 to 36 months after implantation]

Вторичные конечные точки (4)

Frequency of inflammatory recurrences and retreatments [Срок оценки: Year -1 before implantation 0 to 36 months after implantation]
Change in systemic anti-inflammatory and immunosuppressive treatment burden [Срок оценки: Baseline (implantation) 12, 24, and 36 months after implantation]
Safety outcomes related to intraocular pressure and ocular complications [Срок оценки: 0 to 36 months after implantation]
Peripapillary retinal nerve fiber layer changes [Срок оценки: Baseline 12, 24, and 36 months after implantation]

Критерии участия

Критерии включения

Adult patients aged 18 years or older
Diagnosis of non-infectious uveitis with posterior segment involvement
Presence of uveitic macular edema or persistent posterior segment inflammation
Treatment with a fluocinolone acetonide intravitreal implant prior to January 2024