Biomarkers in Ocular Inflammation and Uveitis
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|ClinicalTrials.gov Identifier: NCT04690829|
Recruitment Status : Completed
First Posted : December 31, 2020
Last Update Posted : November 18, 2022
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.
To find biomarkers to better understand uveitic diseases, assess disease severity, and create outcome measures of response to treatment and disease activity.
People ages 4 and older from certain NEI studies who have uveitis or ocular inflammation, and healthy volunteers
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.
|Condition or disease|
|Uveitis Ocular Inflammation|
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.
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
Study Duration: Estimated study duration is 5 years
|Study Type :||Observational|
|Actual Enrollment :||69 participants|
|Official Title:||Biomarkers in Ocular Inflammation and Uveitis|
|Actual Study Start Date :||December 29, 2020|
|Actual Primary Completion Date :||November 16, 2022|
|Actual Study Completion Date :||November 16, 2022|
control with non-inflammatory related eye disease
control (healthy participant)
patients with a diagnosis of uveitis or ocular inflammation
- identify associations in laboratory markers [ Time Frame: at baseline ]identify associations in laboratory markers with disease etiology
- changes in ocular imaging findings [ Time Frame: pre- and post treatment ]changes in ocular imaging findings including as OCT, OCTA, FA, ICG
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04690829
|United States, Maryland|
|National Eye Institute (NEI)|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Tiarnan DL Keenan, M.D.||National Eye Institute (NEI)|