Biomarkers in Ocular Inflammation and Uveitis

NCT04690829 | Completed

• 2 other identifiers: 10000209000209-EI
• Study Type: observational
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Uveitis; Ocular Inflammation

Keywords

Ocular imaging; Laboratory mARKERS; Natural History

Outcome Measures

Primary Outcomes (2)

• identify associations in laboratory markers

  identify associations in laboratory markers with disease etiology

  at baseline

• changes in ocular imaging findings

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

  pre- and post treatment

Study Arms (3)

control

control with non-inflammatory related eye disease

control (healthy participant)

healthy volunteer

uveitis

patients with a diagnosis of uveitis or ocular inflammation

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Study participants evaluated at the NIH clinical center under a NIH approved protocol

You may qualify if:

• The study population will include subjects aged 4 or older and no upper limit for age will be set. All data will be derived only from subjects evaluated at the NEI eye clinic and enrolled in NEI protocols. This also applies to data from healthy volunteers.
• Subjects evaluated under the IRB protocols.
• AND
• Have a diagnosis of uveitis, ocular inflammation, scleritis or a disease known to be associated with intraocular inflammation, (e.g., sarcoidosis, Beh(SqrRoot)(Beta)et s disease, multiple sclerosis (MS) and lymphoma or COVID-19 or other infections)
• Serve as a control:
• unaffected control (healthy volunteer) or
• control with non-inflammatory related eye disease

Sponsors & Collaborators

• National Eye Institute (NEI): lead

Study Sites (1)

National Eye Institute (NEI)

Bethesda, Maryland, 20892, United States

Location

MeSH Terms

Conditions

Uveitis

Condition Hierarchy (Ancestors)

Uveal Diseases; Eye Diseases

Study Officials

• Tiarnan DL Keenan, M.D.

  National Eye Institute (NEI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2020
• First Posted: December 31, 2020
• Study Start: December 29, 2020
• Primary Completion: November 16, 2022
• Study Completion: November 16, 2022
• Last Updated: September 19, 2024

Record last verified: 2024-04-15

Locations

US (1)