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Biomarkers in Ocular Inflammation and Uveitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04690829
Recruitment Status : Completed
First Posted : December 31, 2020
Last Update Posted : November 18, 2022
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Eye Institute (NEI) )

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.


Condition or disease
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

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Study Type : Observational
Actual Enrollment : 69 participants
Observational Model: Other
Time Perspective: Retrospective
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

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. identify associations in laboratory markers [ Time Frame: at baseline ]
    identify associations in laboratory markers with disease etiology

  2. changes in ocular imaging findings [ Time Frame: pre- and post treatment ]
    changes in ocular imaging findings including as OCT, OCTA, FA, ICG



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Study participants evaluated at the NIH clinical center under a NIH approved protocol
Criteria
  • 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.


Information from the National Library of Medicine

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


Locations
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United States, Maryland
National Eye Institute (NEI)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Eye Institute (NEI)
Investigators
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Principal Investigator: Tiarnan DL Keenan, M.D. National Eye Institute (NEI)
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Responsible Party: National Eye Institute (NEI)
ClinicalTrials.gov Identifier: NCT04690829    
Other Study ID Numbers: 10000209
000209-EI
First Posted: December 31, 2020    Key Record Dates
Last Update Posted: November 18, 2022
Last Verified: November 16, 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Eye Institute (NEI) ):
Ocular imaging
Laboratory mARKERS
Natural History
Additional relevant MeSH terms:
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Uveitis
Inflammation
Pathologic Processes
Uveal Diseases
Eye Diseases