Biomarkers in Ocular Inflammation and Uveitis

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.

Study Overview

• Status: Completed
• Conditions: Uveitis; Ocular Inflammation

Detailed Description

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

Study Duration: Estimated study duration is 5 years

• Study Type: Observational
• Enrollment (Actual): 69

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Bethesda, Maryland, United States, 20892
      • National Eye Institute (NEI)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 months and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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

Description

• INCLUSION CRITERIA:

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.

1. Subjects evaluated under the IRB protocols.

   AND

2. 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)

   OR

3. Serve as a control:

   1. unaffected control (healthy volunteer) or
   2. control with non-inflammatory related eye disease

EXCLUSION CRITERIA:

1. 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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Retrospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
control; control with non-inflammatory related eye disease
control (healthy participant); healthy volunteer
uveitis; patients with a diagnosis of uveitis or ocular inflammation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: National Eye Institute (NEI)
• Investigators: Principal Investigator: Tiarnan DL Keenan, M.D., National Eye Institute (NEI)

Study record dates

Study Major Dates

• Study Start (Actual): December 29, 2020
• Primary Completion (Actual): November 16, 2022
• Study Completion (Actual): November 16, 2022

Study Registration Dates

• First Submitted: December 30, 2020
• First Submitted That Met QC Criteria: December 30, 2020
• First Posted (Actual): December 31, 2020

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 15, 2024

More Information

Terms related to this study

• Keywords: Natural History; Ocular imaging; Laboratory mARKERS
• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Uveal Diseases; Inflammation; Uveitis
• Other Study ID Numbers: 10000209; 000209-EI

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No