UveitisNCT02656381
Uveitis/Intraocular Inflammatory Disease Biobank (iBank)
An observational study of Uveitis, run by National Eye Institute (NEI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 100 years
- Conditions the study is for
- Uveitis
- How many people
- 343 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jul 2016to 4 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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 (e.g., sarcoidosis, Beh(SqrRoot)(Beta)et's disease, multiple sclerosis (MS) and lymphoma). In addition, 100 participants without intraocular inflammatory disease will be enrolled as controls.
Who may be able to join
- Participants will be eligible if they:
- Have a diagnosis of uveitis, scleritis or a disease known to be associated with intraocular inflammation, (e.g., sarcoidosis, Behcet's disease, MS and lymphoma) OR could serve as an unaffected control.
- Are eight years of age or older if an affected participant.
- Are 18 years of age or older if serving as an unaffected control.
- 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.
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- Participants with COVID-19 will be eligible if they:
- Have a diagnosis of COVID-19 confirmed by a nasopharyngeal 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.
Who cannot join
- Participants will not be eligible if they:
- Are unable to understand and sign the informed consent form.
- 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.
- Have a systemic disease that compromises the ability to provide adequate ophthalmologic examination or treatment as determined by the investigator.
- 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.
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- 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.
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
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.
Read more
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:
- 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.
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.
Read the 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 (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/or 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.
- Conditions
- Uveitis
- Keywords
- Sarcoidosis, Behcet's Disease, Natural History Study, Biological Specimens, Immune System, Natural History
- Medical subject headings
- Uveitis, Sarcoidosis, Behcet Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
Measured: 7 years
Secondary outcomes (1)
Secondary outcomes will include the number and severity of systemic and ocular adverse events among participants who use systemic immunosuppression.
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
Measured: 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2016 (estimated)
- Study start26 Jul 2016
- Primary completion4 May 2023
- Study completion4 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for UveitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 343 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Eye Institute (NEI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Emily Y Chew, M.D., Principal investigator, National Eye Institute (NEI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02656381
- Sponsor's protocol ID
- 160046
- Other IDs
- 16-EI-0046
- Status last verified
- 24 Apr 2026
- First submitted
- 13 Jan 2016
- Last updated
- 27 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Wei J, Mattapallil MJ, Horai R, Jittayasothorn Y, Modi AP, Sen HN, Gronert K, Caspi RR. A novel role for lipoxin A4 in driving a lymph node-eye axis that controls autoimmunity to the neuroretina. Elife. 2020 Mar 2;9:e51102. doi: 10.7554/eLife.51102.
PubMed 32118582
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Uveitis/Intraocular Inflammatory Disease Biobank (iBank)
- ClinicalTrials.gov ID
- NCT02656381
- Acronym / sponsor ID
- 160046
- Conditions
- Uveitis
- Keywords
- Sarcoidosis, Behcet's Disease, Natural History Study, Biological Specimens, Immune System, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 343 participants (actual)
- Lead sponsor
- National Eye Institute (NEI)US National Institutes of Health
- Study start
- 26 Jul 2016 (actual)
- Primary completion
- 4 May 2023 (actual)
- Study completion
- 4 May 2023 (actual)
- First posted
- 14 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
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 (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/or 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 8 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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 (e.g., sarcoidosis, Beh(SqrRoot)(Beta)et's disease, multiple sclerosis (MS) and lymphoma). In addition, 100 participants without intraocular inflammatory disease will be enrolled as controls.
Key inclusion criteria (10 listed)
- Have a diagnosis of uveitis, scleritis or a disease known to be associated with intraocular inflammation, (e.g., sarcoidosis, Behcet's disease, MS and lymphoma) OR could serve as an unaffected control.
- Are eight years of age or older if an affected participant.
- Are 18 years of age or older if serving as an unaffected control.
- For participants 18 years of age and older:
- Have a diagnosis of COVID-19 confirmed by a nasopharyngeal swab (or another confirmative test) within less than or equal to 3 days prior, with symptoms of any severity.
Key exclusion criteria (11 listed)
- Are unable to understand and sign the informed consent form.
- 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.
- Have a systemic disease that compromises the ability to provide adequate ophthalmologic examination or treatment as determined by the investigator.
- For participants with uveitis:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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: 7 years
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.
1 secondary outcome
Secondary outcomes will include the number and severity of systemic and ocular adverse events among participants who use systemic immunosuppression.
Time frame: 7 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Derived from this study: PubMed 32118582Wei J, Mattapallil MJ, Horai R, Jittayasothorn Y, Modi AP, Sen HN, Gronert K, Caspi RR. A novel role for lipoxin A4 in driving a lymph node-eye axis that controls autoimmunity to the neuroretina. Elife. 2020 Mar 2;9:e51102. doi: 10.7554/eLife.51102.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emily Y Chew, M.D. principal investigator
National Eye Institute (NEI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Uveitis, run by National Eye Institute (NEI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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: 7 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02656381, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.