Uveitis/Intraocular Inflammatory Disease Biobank (iBank)

NCT02656381 | Completed

• 2 other identifiers: 16004616-EI-0046
• Study Type: observational
• Target: 343
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Uveitis is a serious eye disease that can cause vision loss. Treatment sometimes causes serious side effects or does not work. Researchers want to learn more about uveitis and why some people develop it. Objective: To learn clinical and genetic factors that may make people develop uveitis and influence how they respond to treatment. Eligibility: People ages 8 and older who have uveitis, scleritis, inflammatory eye disease, or a disease related to eye inflammation INCLUSION CRITERIA FOR COVID-19 COHORT: Participants with COVID-19 will be eligible if they:

1. 1.Have a diagnosis of COVID-19 confirmed by a nasaopharyngeal swab (or another confirmative test) within less than or equal to 3 days prior, with symptoms of any severity.
2. 2.Are able to give verbal consent.
3. 3.Are 16 years of age or older.
4. 4.Use regular prescription eye drops on the day of sampling.
5. 5.Current use of antiviral medications.

Conditions

Uveitis

Keywords

Sarcoidosis; Behcet's Disease; Natural History Study; Biological Specimens; Immune System; Natural History

Outcome Measures

Primary Outcomes (1)

• The clinical data and samples from this study will be used to test for interaction of key parameters of phenotype with genetic variants and other biomarkers identified from biospecimens.

  The intent is to collect data on a variety of phenotypic pararmeters and to store biospecimens in a manner that permits a broad array of potnential testing and experimentation in the future.

  7 years

Secondary Outcomes (1)

• Secondary outcomes will include the number and severity of systemic and ocular adverse events among participants who use systemic immunosuppression.

  7 years

Study Arms (4)

Anterior Uveitis

Participants with AU at entry

Intermediate Uveitis

Participants with IU at entry

Other

Participants not fitting above criteria

Posterior/Pan Uveitis

Participants with non-infectious posterior or pan-uveitis

Eligibility Criteria

• Age: 8 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study plans to accrue 550 participants with uveitis or related diseases. This will not be restricted by anatomical location or etiology with the inclusion of both idiopathic cases, infectious uveitis, scleritis and those cases linked to a disease known to be associated with an increased risk of intraocular inflammation (e.g., sarcoidosis, Beh(SqrRoot)(Beta)et's disease, multiple sclerosis (MS) and lymphoma). In addition, 100 participants without intraocular inflammatory disease will be enrolled as controls.

You may qualify if:

• Participants will be eligible if they:
• Have a diagnosis of uveitis, scleritis or a disease known to be associated with intraocular inflammation, (e.g., sarcoidosis, Behcet's disease, MS and lymphoma) OR could serve as an unaffected control.
• Are eight years of age or older if an affected participant.
• Are 18 years of age or older if serving as an unaffected control.
• For participants 18 years of age and older:
• Are willing to give informed consent that includes collection and study of at least one peripheral blood sample.

You may not qualify if:

• Participants will not be eligible if they:
• Are unable to understand and sign the informed consent form.
• Are unable or unwilling to give informed consent that includes use of medical records and clinical samples for current and future research related to vision and diseases affecting the eyes.
• Have a systemic disease that compromises the ability to provide adequate ophthalmologic examination or treatment as determined by the investigator.
• For participants with uveitis:
• Have inactive anterior uveitis or quiescent infectious uveitis not requiring such regimented and intensive standardized testing as determined by the Investigator.
• Have end stage or chronic quiescent changes in the setting of an established infectious etiology, such as an old ocular toxoplasma scar (participants with active intraocular inflammation due to infection will be recruited).
• The eligibility requirements for this protocol are intended to be broadly inclusive, but those individuals screened at the NEI and found to be ineligible may be evaluated under the NEI Screening Protocol for potential participation in other studies.
• Participants with COVID-19 will be eligible if they:
• Have a diagnosis of COVID-19 confirmed by a nasopharyngeal swab (or another confirmative test) within less than or equal to 3 days prior, with symptoms of any severity.
• Are able to give verbal consent.
• Are 16 years of age or older.
• Participants with COVID-19 will not be eligible if they:
• Use regular prescription eye drops on the day of sampling.
• Current use of antiviral medications.

Sponsors & Collaborators

• National Eye Institute (NEI): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Publications (1)

• Wei J, Mattapallil MJ, Horai R, Jittayasothorn Y, Modi AP, Sen HN, Gronert K, Caspi RR. A novel role for lipoxin A4 in driving a lymph node-eye axis that controls autoimmunity to the neuroretina. Elife. 2020 Mar 2;9:e51102. doi: 10.7554/eLife.51102.

  PMID: 32118582 DERIVED

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Uveitis; Sarcoidosis; Behcet Syndrome

Condition Hierarchy (Ancestors)

Uveal Diseases; Eye Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases; Mouth Diseases; Stomatognathic Diseases; Uveitis, Anterior; Panuveitis; Vasculitis; Vascular Diseases; Cardiovascular Diseases; Hereditary Autoinflammatory Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Vascular

Study Officials

• Emily Y Chew, M.D.

  National Eye Institute (NEI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2016
• First Posted: January 14, 2016
• Study Start: July 26, 2016
• Primary Completion: May 4, 2023
• Study Completion: May 4, 2023
• Last Updated: April 1, 2026

Record last verified: 2025-09-10

Locations

US (1)