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Идёт набор NCT05592717

A Study of YUTIQ® 0.18 mg Intravitreal Implant for the Management of Chronic Non-infectious Uveitis

— Наблюдательное Uveitis YUTIQ

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: Yutiq.
Кому может быть актуально
Состояния в реестре: Uveitis, YUTIQ. Базовые параметры: 18 лет — 70 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
Китай
Следующий шаг
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Официальное название

An Observational Study of YUTIQ (Fluocinolone Acetonide Intravitreal Implant 0.18 mg) for the Management of Chronic Non-infectious Uveitis

Обзор

This project is designed to evaluate the efficacy of YUTIQ® 0.18 mg intravitreal implant for the management of chronic non-infectious uveitis.

Подробное описание

Approval of the study was obtained from the hospital's ethical committee. The study design and methodology followed the tenets of Declaration of Helsinki. All patients were provided with written informed consent and received a thorough explanation of the use of Yutiq, its potential risks and benefits. This is a monocenter, cohort, observational study evaluating patients with chronic non-infectious uveitis divided into two groups: Yutiq therapy group and traditional therapy group.

For Yutiq therapy group, patients will receive YUTIQ® 0.18 mg as an intravitreal injection in the designated study eye. For the traditional therapy group, patients were treated with glucocorticoids alone or glucocorticoids combined with immunosuppressants. Study participants will be followed for up to 3 years to determine efficacy and side effects.

According to best corrected visual acuity (BCVA), anterior chamber and vitreous inflammation, optical coherence tomography (OCT), change in corticosteroid dose during the study period and so on. The investigators evaluate the anti-inflammatory and reducing relapses effects of Yutiq in treatment of chronic non-infectious uveitis.

Вмешательства

  • Препарат Yutiq
    YUTIQ® 0.18 mg as an intravitreal injection in the designated study eye.

Первичные конечные точки

  • Change In LogMAR Best Corrected Visual Acuity (BCVA) From Baseline to Each Visit. [Срок оценки: 12 months]
  • Recurrence rates [Срок оценки: 36 months]
Вторичные конечные точки (2)
  • Change in Anterior Chamber (AC) Cell Grade From Baseline to Each Visit [Срок оценки: 12 months]
  • Prednisone exposure [Срок оценки: 36 months]

Критерии участия

Критерии включения

  • Male or female in good general health at 18 to 70 years of age.
  • Presence of unilateral or bilateral non-infectious uveitis affecting the posterior segment
  • Patients have active inflammation before Yutiq treatment. Subject meets at least 1 of the following criteria: 1. ≥1+ anterior chamber cell and/or ≥1+ vitreous haze. 2. Fluorescein angiography demonstrates leakages. 3. OCT images showing the macular edema. 4. The times of relapse in one year are equal to or greater than 3.
  • Steroids and immunosuppressive agents were discontinued within 3 months after Yutiq injection.

Критерии исключения

  • Subject with corneal or lens opacity that precludes visualization of the fundus or that likely requires cataract surgery during the duration of the trial.
  • Subject with a history of neurologic symptoms suggestive of central nervous system demyelinating disease.
  • Prior intravitreal treatment with Retisert®, ILUVIEN®, or YUTIQ® (0.18 mg) within 36 months prior to Day 1.
  • Prior intravitreal treatment with OZURDEX® within 12 weeks prior to Day 1. Prior intravitreal treatment with Triesence® or TRIVARIS™ (triamcinolone) within 12 weeks prior to Day 1.
  • Peri-ocular or subtenon steroid treatment within 12 weeks prior to Day 1.
  • Media opacity precluding evaluation of retina and vitreous (eg, vitreous hemorrhage).
  • Hypersensitivity to any of the ingredients contained in YUTIQ®.
  • Any other systemic or ocular condition which, in the judgment of the Investigator, could make the subject inappropriate for study enrollment.
  • Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of contraception as outlined in the protocol from at least 14 days prior to Day 1 until the final study visit.

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

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Китай · 1 центр
  • Tianjin Medical University Eye Hospital — Тяньцзинь

Идентификаторы

NCT: NCT05592717 · 2022KY-17

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗