Biomarkers in Ocular Inflammation and Uveitis

Completed

Conditions studied: Uveitis, Ocular Inflammation

In brief

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.

Key facts

Study ID

NCT04690829

Run by

National Eye Institute (NEI)

People needed

69

Starts

2020-12-29

Expected to finish

2022-11-16

Last updated by the study team

2024-09-19

Who can join

Age: 2 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Patients without appropriate diagnostic and laboratory investigations for their diagnosis. Disease specific exclusion criteria will also be used. Patients will be excluded if appropriate laboratory investigations were not performed such as infectious serological tests and autoimmune labs. For posterior segment uveitis with retinal vasculitis, patients without fluorescein angiography will be excluded. Similarly, patients with choroiditis will be excluded if fundus autofluorescence studies were not performed. These disease specific exclusion criteria do not apply to healthy volunteers.
• Patients who were minors and NIH employees will be included in this retrospective study. The IRB approved protocols which these patients were managed under allow for the inclusion of these populations at time of original consent.

Where it is running

• National Eye Institute (NEI) — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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