Ignite Creation Date:
2024-05-06 @ 8:02 AM
Last Modification Date:
2024-10-26 @ 11:55 AM
Study NCT ID:
NCT02656381
Status:
COMPLETED
Last Update Posted:
2024-07-12
First Post:
2016-01-13
Brief Title:
UveitisIntraocular Inflammatory Disease Biobank iBank
Sponsor:
National Eye Institute NEI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
UveitisIntraocular Inflammatory Disease Biobank iBank
Status:
COMPLETED
Status Verified Date:
2024-07-23
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 eg sarcoidosis BehSqrRoot Betaets 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 andor 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
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 eg sarcoidosis BehSqrRoot Betaets 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 andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 16-EI-0046 | None | None | None |