Uveitis/Intraocular Inflammatory Disease Biobank (iBank)
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|ClinicalTrials.gov Identifier: NCT02656381|
Recruitment Status : Recruiting
First Posted : January 14, 2016
Last Update Posted : May 7, 2020
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.
To learn clinical and genetic factors that may make people develop uveitis and influence how they respond to treatment.
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:
- 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.
- Are able to give verbal consent.
- Are 16 years of age or older.
EXCLUSION CRITERIA FOR COVID-19 COHORT:
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.
Participants will be screened with:
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.
|Condition or 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:
- A standardized follow-up and testing schedule with standard-of-care management of eye diseases; and
- 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.
|Study Type :||Observational|
|Estimated Enrollment :||650 participants|
|Official Title:||Uveitis/Intraocular Inflammatory Disease Biobank (iBank)|
|Actual Study Start Date :||July 26, 2016|
|Estimated Primary Completion Date :||December 31, 2029|
|Estimated Study Completion Date :||December 31, 2029|
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. [ Time Frame: ongoing ]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.
- Secondary outcomes will include the number and severity of systemic and ocular adverse events among participants who use systemic immunosuppression. [ Time Frame: ongoing ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02656381
|Contact: Dominic Obiyor, R.N.||(301) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 firstname.lastname@example.org|
|Principal Investigator:||Hatice N Sen, M.D.||National Eye Institute (NEI)|