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临床试验/NCT04690829
NCT04690829已完成不适用

Biomarkers in Ocular Inflammation and Uveitis

National Eye Institute (NEI)1 个研究点 分布在 1 个国家目标入组 69 人开始时间: 2020年12月29日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
69
试验地点
1
主要终点
changes in ocular imaging findings

研究概览

简要总结

Background:

Uveitis refers to a large group of inflammatory diseases in the eye. The inflammation can be caused by many factors, such as trauma, medicine, or infection. It can also be caused by systemic diseases. Uveitis and ocular inflammation can cause vision loss. Both children and adults can have uveitis. Standard treatment is to suppress the immune system. But this can result in high costs as well as bad side effects. Researchers want to look at data from NEI studies. They want to learn more about how uveitis progresses and responds to treatment.

Objective:

To find biomarkers to better understand uveitic diseases, assess disease severity, and create outcome measures of response to treatment and disease activity.

Eligibility:

People ages 4 and older from certain NEI studies who have uveitis or ocular inflammation, and healthy volunteers

Design:

Data will be taken from NEI studies from January 1, 2000, to December 31, 2025. Data will only be collected for participants who agreed to let their data be used for future research. No new tests will be done on any samples.

Laboratory results and images will be used. Medical chart data, such as symptoms, medicine history, and treatment course, will be used. Personal data, such as name, medical record number, and date of birth, will be used.

COVID-19 has been reported to cause eye changes. Exam findings of participants who had COVID-19 will be reviewed as well.

Machine learning will be used to study the data.

This study will take place at the NIH Clinical Center. All data will be securely stored.

详细描述

Study Description: Uveitis refers to a large group of intraocular inflammatory diseases that can cause devastating visual loss in adults and children. This is a retrospective study to identify factors and biomarkers that are relevant to the pathogenesis, progression, and treatment response in inflammatory eye conditions.

Objectives:

The primary objective is to identify ocular imaging, clinical and laboratory biomarkers in order to better classify presentations of uveitic diseases, assess disease severity and develop outcome measures of response to treatment. The secondary objectives are to identify etiological factors for uveitic diseases including through using a machine-learning approach with external collaborators.

Study Population: The study population will be any patient with a diagnosis of uveitis or ocular inflammation enrolled in an IRB approved protocol since 2000.

Description of Sites/Facilities conducting research: Research will be conducted at the National Institutes of Health clinical center

研究设计

研究类型
Observational
观察模型
Other
时间视角
Retrospective

入排标准

年龄范围
2 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

changes in ocular imaging findings

时间窗: pre- and post treatment

changes in ocular imaging findings including as OCT, OCTA, FA, ICG

identify associations in laboratory markers

时间窗: at baseline

identify associations in laboratory markers with disease etiology

次要结局

未报告次要终点

研究者

申办方类型
Nih
责任方
Sponsor

研究点 (1)

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