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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 : March 25, 2019
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Eye Institute (NEI) )

Brief 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

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.


Condition or disease
Uveitis

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 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.


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Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Uveitis/Intraocular Inflammatory Disease Biobank (iBank)
Study Start Date : January 13, 2016
Estimated Primary Completion Date : January 4, 2036
Estimated Study Completion Date : January 4, 2036

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Secondary outcomes will include the number and severity of systemic and ocular adverse events among participants who use systemic immunosuppression. [ Time Frame: ongoing ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   8 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
  • INCLUSION CRITERIA:

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:

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. Participant is an NEI employee or subordinate or co-worker of an investigator.
  5. 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)

Information from the National Library of Medicine

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


Contacts
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Contact: Dominic Obiyor, R.N. (301) 435-4556 dobiyor@mail.nih.gov

Locations
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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    prpl@cc.nih.gov   
Sponsors and Collaborators
National Eye Institute (NEI)
Investigators
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Principal Investigator: Hatice N Sen, M.D. National Eye Institute (NEI)

Additional Information:
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Responsible Party: National Eye Institute (NEI)
ClinicalTrials.gov Identifier: NCT02656381     History of Changes
Other Study ID Numbers: 160046
16-EI-0046
First Posted: January 14, 2016    Key Record Dates
Last Update Posted: March 25, 2019
Last Verified: March 19, 2019

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Eye Institute (NEI) ):
Sarcoidosis
Behcet's Disease
Natural History Study
Biological Specimens
Immune System

Additional relevant MeSH terms:
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Uveitis
Uveal Diseases
Eye Diseases