Prospective CoHoRt Of Non-infectious Intermediate, pOsterior or panuveitiS

Обзор

prospective, cohort, longitudinal, multicenter, non-randomized study of patients with non-infectious posterior segment uveitis or panuveitis, with a group of control patients (scheduled for cataract or vitreoretinal surgery) and constitution of biological collection.

Подробное описание

Description of the clinical characteristics and evolution in a large cohort of patients with non-infectious uveitis, allowing to identify prognostic or predictive factors of response after treatment of these different forms of non-infectious uveitis of the posterior segment or panuveitis (factors that are currently not well known).

Uveitis patients:

* Blood sample (20ml): Additional 20 ml blood sample during the first visit and potentially during follow-up (if necessary) for the purpose of the biological collection; * Ocular sample (aqueous humor, vitreous): if required by the clinical context for the needs of the biological collection; * Specific imaging: adaptive optics or Doppler holography, these procedures will be indicated on a case-by-case basis, at the investigator's discretion, and concern only patients with inflammatory vascular damage (5 to 10% of patients in the uveitis cohort); * Quality of Life NEI-VFQ 25: provided at the inclusion visit and at follow-up visits M3-V2, M12-V5 and M24-V7.

Control patients:

* Blood sample (20ml): Additional 20 ml blood sample during the inclusion visit at the time of the surgical scheduled procedure for the needs of the biological collection; * Ocular sample (aqueous humor, vitreous): considered as surgical waste, the tissue residues will be collected during the scheduled surgical procedure for cataract or vitreoretinal surgery for the needs of the biological collection;

Вмешательства

• Диагностический тест care strategy
  Uveitis patients: * Blood sample (20ml): Additional 20 ml blood sample during the first visit and potentially during follow-up (if necessary) for the purpose of the biological collection; * Ocular sample (aqueous humor, vitreous): if required by the clinical context for the needs of the biological collection; * Specific imaging: adaptive optics or Doppler holography, these procedures will be indicated on a case-by-case basis, at the investigator's discretion, and concern only patients with infl

Первичные конечные точки

• Imaging database development [Срок оценки: 60 months]
• Biological constitution [Срок оценки: 60 months]
• medico economic costs estimation [Срок оценки: 60 months]

Критерии участия

Критерии включения

UVEITIS Patients:

• Adult patients (≥ 18 years);
• Non-infectious uveitis;
• Intermediate, posterior or panuveitis;
• Inflammatory activity requiring treatment with either one or more of the followings:

• Systemic corticosteroids or periocular or intravitreal injections of corticosteroids;
• Immunosuppressants: methotrexate, azathioprine, cyclosporine, etc.;
• Biotherapy: infliximab, adalimumab, tocilizumab;
• Patients with health insurance;
• Written Informed consent obtained at enrolment in the study.

Control patients:

• Adult patients (≥ 18 years);
• Scheduled patients ( Non-urgente procedure) for cataract or vitreoretinal surgery;
• Patients with health insurance;
• Written Informed consent obtained at enrolment in the study.

Критерии исключения

Uveitis Patients:

• Isolated anterior uveitis ;
• Inactive disease defined as:

• Absence of inflammatory chorioretinal and/or inflammatory retinal vascular lesion;
• Anterior chamber cell grade< 0.5+;
• Vitreous haze grade <0.5+;
• Pregnant or breastfeeding woman at the inclusion visit;
• Patient under legal protection (" curatelle " or " tutelle ");
• Patient denied freedom by a legal or administrative order.

Control patients:

• Pregnant or breastfeeding woman;
• Unscheduled (urgent) cataract or vitreoretinal surgery;
• Patient under legal protection (" curatelle " or " tutelle ");
• Patient denied freedom by a legal or administrative order.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT05928754 · P22-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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