Uveitis/Intraocular Inflammatory Disease Biobank (iBank)



Status:Recruiting
Conditions:Cervical Cancer, Ocular
Therapuetic Areas:Oncology, Ophthalmology
Healthy:No
Age Range:8 - Any
Updated:3/27/2019
Start Date:January 13, 2016
End Date:January 4, 2036
Contact:Dominic Obiyor, R.N.
Email:dobiyor@mail.nih.gov
Phone:(301) 435-4556

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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.

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:

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)
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Phone: 800-411-1222
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mi
from
Bethesda, MD
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