Targeting Immunosuppressive Treatment for Non-infectious Uveitis Using Aqueous Humor Cytokine Profiles
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 220
- 试验地点
- 6
- 主要终点
- Aqueous humor cytokine profile characterization in responders vs non-responders using multiplex immunoassay techniques.
研究概览
简要总结
This multicenter, prospective, interventional, non-pharmacological study aims to investigate whether the intraocular cytokine profile is associated with the therapeutic response to immunosuppressive drugs in patients with non-infectious uveitis (NIU). Approximately 220 patients with NIU in at least one eye, showing inadequate response to topical or systemic corticosteroids at baseline and presenting with signs of anterior segment inflammation, will be enrolled to enhance sensitivity to laboratory assays. Aqueous humor and blood samples will be collected at baseline. Cytokine concentrations of 14 different cytokines will be measured using multiplex immunoassay techniques. Participants will receive immunosuppressive treatment based on standard clinical practice.
详细描述
This project is coordinated by University of Milan/ ASST FBF Sacco Milan Italy. Site coordinator has a sub-Unit (AUSL Reggio Emilia Italy) which act both as recruiter and Lab analyst.
Site co-partner is: IRCCS San Raffaele, University Vita e Salute San Raffaele Milan Italy
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of non-infectious uveitis in at least one eye with incomplete or not sustained response to topic or systemic steroids at the baseline visit
- •Evidence of anterior chamber inflammation to optimize lab sensibility
- •As per clinical practice eligibility to receive one of the following immunosuppressive treatment: mycophenolate mofetil (MMF), methotrexate (MTX), azatioprine (AZA), adalimumab (ADA)
- •Ability to provide informed consent
排除标准
- •Concomitant immunosuppressive treatment
- •Presence of other systemic pathologies that do not allow immunosuppressive therapies
- •Ocular media opacities that could interfere with a good quality of fundus exam and/or imaging of the eye
- •Any ocular or systemic condition that could interfere with cytokine profile expressions
- •Pregnancy or breastfeeding
结局指标
主要结局
Aqueous humor cytokine profile characterization in responders vs non-responders using multiplex immunoassay techniques.
时间窗: Three months from baseline
Distribution of responders and non responders to each study drug according to baseline cytokine profile in the aqueous humor.
次要结局
- Correlation between cytokine levels in the aqueous humor and blood(Baseline)
- Correlation cytokine profiles and patients' clinical evaluation(Baseline vs three months)
- Correlation between clinical ophthalmic features and cytokine profiles(baseline and three months)
研究者
Alessandro Invernizzi
Professor of Ophthalmology
University of Milan