Uveitis/Intraocular Inflammatory Disease Biobank (iBank)

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 8 Years and Over
Gender All
More Inclusion & Exclusion Criteria

  • - 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT02656381
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

National Eye Institute (NEI)
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Hatice N Sen, M.D.
Principal Investigator Affiliation National Eye Institute (NEI)
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

NIH
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Uveitis
Study Website: View Trial Website
Additional Details

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.

Arms & Interventions

Arms

: 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

Interventions

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Bethesda, Maryland

Status

Recruiting

Address

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892

Site Contact

For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)

[email protected]

800-411-1222 #TTY8664111010