An observational study in Uveitis, sponsored by National Eye Institute (NEI). Completed at 1 site in United States. Open to participants aged 8 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by National Eye Institute (NEI) · Observational
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:
EXCLUSION CRITERIA FOR COVID-19 COHORT:
Participants with COVID-19 will not be eligible if they:
Design:
Participants will be screened with:
Medical history
Physical exam
Eye exam
Participation lasts up to 10 years. The clinic visit schedule varies depending on participants eye disease:
Baseline visit with annual follow-ups
Baseline visit, visits at months 3 and 6, and annual follow-ups
Another schedule set by the researcher
Depending on participants eye disease, tests during each visit could include:
Fluorescein angiography or indocyanine green angiography: Dye is injected through a needle in the arm
and flows through the blood vessels in the eye. A camera takes pictures of the eye.
Electroretinography: Participants sit in the dark with their eyes patched.
After 30 minutes, numbing drops and contact lenses are put in the eyes. Then, the retina is stimulated with flashing lights.
Perimetry: Participants look into a bowl or lens and press a button when they see a light.
Conjunctival or corneal biopsy, or skin biopsy: A small piece of tissue is removed.
Anterior chamber tap: A needle enters the eye to remove fluid.
Blood and urine tests
Saliva, stool, hair, or tear samples
Cotton swab of the inside of the cheek.
During the study, participants may need immunosuppressive treatment, such as drugs or injections in or around the eyes depending on their disease.
Uveitis refers to a large group of intraocular inflammatory diseases that can cause devastating visual loss in adults and children. This study establishes a clinical database and biospecimen repository for the identification of novel factors relevant to the pathogenesis, progression, and response to treatment of a wide spectrum of uveitic conditions.
Objectives: This study provides for standardized collection of longitudinal clinical data and for serial collection, processing, and storage of a variety of biospecimens. The clinical data set and biospecimen repository will be used to identify novel genetic factors, biomarkers, and experimental models associated with pathogenesis, progression, and response to treatment for various ocular and systemic conditions where inflammation of the uveal tract is present.
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 and multiple sclerosis (MS) and lymphoma). In addition, 100 participants without intraocular inflammatory disease will be enrolled as controls.
Design: This is a prospective observational study of participants with intraocular inflammatory diseases incorporating: 1. A standardized follow-up and testing schedule with standard-of-care management of eye diseases; and/or 2. Collection of biospecimens for research purposes for which sampling does not incur more than minimal risk to participants. Outcome Measures: Outcome measures include the interaction of key parameters of disease phenotype (such as visual acuity and ocular imaging features) with genetic variants and other biomarkers identified from biospecimens and the characterization of new experimental models of eye health and disease.
299 studies on the registry are indexed under Uveitis; 32 are open to participants now.
This study's enrollment of 343 is above the median of 107 across 104 observational studies indexed under Uveitis.
Browse Uveitis studies →National Eye Institute (NEI) is the lead sponsor of 272 studies on the registry; 17 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 8 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participants will be eligible if they:
For participants 18 years of age and older:
EXCLUSION CRITERIA (NOT APPLICABLE TO COVID COHORT):
Participants will not be eligible if they:
For participants with uveitis:
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.
INCLUSION CRITERIA FOR COVID-19 COHORT:
Participants with COVID-19 will be eligible if they:
EXCLUSION CRITERIA FOR COVID-19 COHORT:
Participants with COVID-19 will not be eligible if they:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants with AU at entry
Participants with IU at entry
Participants not fitting above criteria
Participants with non-infectious posterior or pan-uveitis
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.
Time frame: 7 years
Secondary outcomes will include the number and severity of systemic and ocular adverse events among participants who use systemic immunosuppression.
Events include but are not limited to structural ocular complications, hospitalizations, osteoporosis, renal and hepatic side effects, infections and myelosuppression from conventional immunosuppressives and biologics
Time frame: 7 years
Plan to share: Undecided
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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