Uveitis/Intraocular Inflammatory Disease Biobank (iBank)
Uveitis/Intraocular Inflammatory Disease Biobank (iBank)
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. 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. Are able to give verbal consent.

 3. Are 16 years of age or older.

 EXCLUSION CRITERIA FOR COVID-19 COHORT:

 Participants with COVID-19 will not be eligible if they:

 1. Use regular prescription eye drops on the day of sampling.

 2. Current use of antiviral medications.

 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 500 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

 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.
-  INCLUSION CRITERIA (NOT APPLICABLE TO COVID COHORT):

 Participants will be eligible if they:

 1. Have a diagnosis of uveitis, scleritis or a disease known to be associated with
 intraocular inflammation, (e.g., sarcoidosis, Behcet's disease, multiple sclerosis
 (MS) and lymphoma) OR could serve as an unaffected control.

 2. Are eight years of age or older if an affected participant.

 3. Are 18 years of age or older if serving as an unaffected control.

 4. 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.

 EXCLUSION CRITERIA (NOT APPLICABLE TO COVID COHORT):

 Participants will not be eligible if they:

 1. Are unable to understand and sign the informed consent form.

 2. 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.

 3. Have a systemic disease that compromises the ability to provide adequate
 ophthalmologic examination or treatment as determined by the investigator.

 4. 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.

 INCLUSION CRITERIA FOR COVID-19 COHORT:

 Participants with COVID-19 will be eligible if they:

 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. Are able to give verbal consent.

 3. Are 16 years of age or older.

 EXCLUSION CRITERIA FOR COVID-19 COHORT:

 Participants with COVID-19 will not be eligible if they:

 1. Use regular prescription eye drops on the day of sampling.

 2. Current use of antiviral medications.