Uveitis/Intraocular Inflammatory Disease Biobank (iBank)
Condition: Uveitis
MeSH terms: Uveitis
Study type: Observational

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. 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.
    

Detailed description: 
      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.
    

Observational model: Cohort
Time perspective: Prospective
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.
      
Keywords: Sarcoidosis; Behcet's Disease; Natural History Study; Biological Specimens; Immune System; Natural History