UveitisNCT04690829
Biomarkers in Ocular Inflammation and Uveitis
An observational study of Uveitis and Ocular Inflammation, run by National Eye Institute (NEI) at 1 site in United States.
Trial summary
Background: Uveitis refers to a large group of inflammatory diseases in the eye. The inflammation can be caused by many factors, such as trauma, medicine, or infection. It can also be caused by systemic diseases. Uveitis and ocular inflammation can cause vision loss. Both children and adults can have uveitis. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Uveitis, Ocular Inflammation
- How many people
- 69 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Dec 2020to 16 Nov 2022
- 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 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Study participants evaluated at the NIH clinical center under a NIH approved protocol
Who may be able to join
- The study population will include subjects aged 4 or older and no upper limit for age will be set. All data will be derived only from subjects evaluated at the NEI eye clinic and enrolled in NEI protocols. This also applies to data from healthy volunteers.
- Subjects evaluated under the IRB protocols.
- AND
- Have a diagnosis of uveitis, ocular inflammation, scleritis or a disease known to be associated with intraocular inflammation, (e.g., sarcoidosis, Beh(SqrRoot)(Beta)et s disease, multiple sclerosis (MS) and lymphoma or COVID-19 or other infections)
- OR
- Serve as a control:
- unaffected control (healthy volunteer) or
- control with non-inflammatory related eye disease
Who cannot join
- 1. Patients without appropriate diagnostic and laboratory investigations for their diagnosis. Disease specific exclusion criteria will also be used. Patients will be excluded if appropriate laboratory investigations were not performed such as infectious serological tests and autoimmune labs. For posterior segment uveitis with retinal vasculitis, patients without fluorescein angiography will be excluded. Similarly, patients with choroiditis will be excluded if fundus autofluorescence studies were not performed. These disease specific exclusion criteria do not apply to healthy volunteers.
- Patients who were minors and NIH employees will be included in this retrospective study. The IRB approved protocols which these patients were managed under allow for the inclusion of these populations at time of original consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Eye Institute (NEI)
Bethesda, Maryland, 20892
About this study
Background:
Uveitis refers to a large group of inflammatory diseases in the eye. The inflammation can be caused by many factors, such as trauma, medicine, or infection. It can also be caused by systemic diseases. Uveitis and ocular inflammation can cause vision loss. Both children and adults can have uveitis. Standard treatment is to suppress the immune system. But this can result in high costs as well as bad side effects. Researchers want to look at data from NEI studies. They want to learn more about how uveitis progresses and responds to treatment.
Read more
Objective:
To find biomarkers to better understand uveitic diseases, assess disease severity, and create outcome measures of response to treatment and disease activity.
Eligibility:
People ages 4 and older from certain NEI studies who have uveitis or ocular inflammation, and healthy volunteers
Design:
Data will be taken from NEI studies from January 1, 2000, to December 31, 2025. Data will only be collected for participants who agreed to let their data be used for future research. No new tests will be done on any samples.
Laboratory results and images will be used. Medical chart data, such as symptoms, medicine history, and treatment course, will be used. Personal data, such as name, medical record number, and date of birth, will be used.
COVID-19 has been reported to cause eye changes. Exam findings of participants who had COVID-19 will be reviewed as well.
Machine learning will be used to study the data.
This study will take place at the NIH Clinical Center. All data will be securely stored.
Read the detailed description
Study Description: Uveitis refers to a large group of intraocular inflammatory diseases that can cause devastating visual loss in adults and children. This is a retrospective study to identify factors and biomarkers that are relevant to the pathogenesis, progression, and treatment response in inflammatory eye conditions.
Objectives:
The primary objective is to identify ocular imaging, clinical and laboratory biomarkers in order to better classify presentations of uveitic diseases, assess disease severity and develop outcome measures of response to treatment. The secondary objectives are to identify etiological factors for uveitic diseases including through using a machine-learning approach with external collaborators.
Study Population: The study population will be any patient with a diagnosis of uveitis or ocular inflammation enrolled in an IRB approved protocol since 2000.
Description of Sites/Facilities conducting research: Research will be conducted at the National Institutes of Health clinical center
Study Duration: Estimated study duration is 5 years
- Conditions
- Uveitis, Ocular Inflammation
- Keywords
- Ocular imaging, Laboratory mARKERS, Natural History
- Medical subject headings
- Uveitis
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 |
|---|---|---|
| control | control with non-inflammatory related eye disease | |
| control (healthy participant) | healthy volunteer | |
| uveitis | patients with a diagnosis of uveitis or ocular inflammation |
What is being measured
The primary outcome is the main question the study is designed to answer.
identify associations in laboratory markers
identify associations in laboratory markers with disease etiology
Measured: at baseline
changes in ocular imaging findings
changes in ocular imaging findings including as OCT, OCTA, FA, ICG
Measured: pre- and post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2020
- Study start29 Dec 2020
- Primary completion16 Nov 2022
- Study completion16 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Eye Institute (NEI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Tiarnan DL Keenan, M.D., Principal investigator, National Eye Institute (NEI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04690829
- Sponsor's protocol ID
- 10000209
- Other IDs
- 000209-EI
- Status last verified
- 15 Apr 2024
- First submitted
- 30 Dec 2020
- Last updated
- 19 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers in Ocular Inflammation and Uveitis
- ClinicalTrials.gov ID
- NCT04690829
- Acronym / sponsor ID
- 10000209
- Conditions
- Uveitis, Ocular Inflammation
- Keywords
- Ocular imaging, Laboratory mARKERS, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- National Eye Institute (NEI)US National Institutes of Health
- Study start
- 29 Dec 2020 (actual)
- Primary completion
- 16 Nov 2022 (actual)
- Study completion
- 16 Nov 2022 (actual)
- First posted
- 31 Dec 2020 (actual)
- 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 refers to a large group of inflammatory diseases in the eye. The inflammation can be caused by many factors, such as trauma, medicine, or infection. It can also be caused by systemic diseases. Uveitis and ocular inflammation can cause vision loss. Both children and adults can have uveitis. Standard treatment is to suppress the immune system. But this can result in high costs as well as bad side effects. Researchers want to look at data from NEI studies. They want to learn more about how uveitis progresses and responds to treatment.
Objective:
To find biomarkers to better understand uveitic diseases, assess disease severity, and create outcome measures of response to treatment and disease activity.
Eligibility:
People ages 4 and older from certain NEI studies who have uveitis or ocular inflammation, and healthy volunteers
Design:
Data will be taken from NEI studies from January 1, 2000, to December 31, 2025. Data will only be collected for participants who agreed to let their data be used for future research. No new tests will be done on any samples.
Laboratory results and images will be used. Medical chart data, such as symptoms, medicine history, and treatment course, will be used. Personal data, such as name, medical record number, and date of birth, will be used.
COVID-19 has been reported to cause eye changes. Exam findings of participants who had COVID-19 will be reviewed as well.
Machine learning will be used to study the data.
This study will take place at the NIH Clinical Center. All data will be securely stored.
Detailed description
Study Description: Uveitis refers to a large group of intraocular inflammatory diseases that can cause devastating visual loss in adults and children. This is a retrospective study to identify factors and biomarkers that are relevant to the pathogenesis, progression, and treatment response in inflammatory eye conditions.
Objectives:
The primary objective is to identify ocular imaging, clinical and laboratory biomarkers in order to better classify presentations of uveitic diseases, assess disease severity and develop outcome measures of response to treatment. The secondary objectives are to identify etiological factors for uveitic diseases including through using a machine-learning approach with external collaborators.
Study Population: The study population will be any patient with a diagnosis of uveitis or ocular inflammation enrolled in an IRB approved protocol since 2000.
Description of Sites/Facilities conducting research: Research will be conducted at the National Institutes of Health clinical center
Study Duration: Estimated study duration is 5 years
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control | – | –control with non-inflammatory related eye disease |
| control (healthy participant) | – | –healthy volunteer |
| uveitis | – | –patients with a diagnosis of uveitis or ocular inflammation |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Study participants evaluated at the NIH clinical center under a NIH approved protocol
Key inclusion criteria (8 listed)
- The study population will include subjects aged 4 or older and no upper limit for age will be set. All data will be derived only from subjects evaluated at the NEI eye clinic and enrolled in NEI protocols. This also applies to data from healthy volunteers.
- Subjects evaluated under the IRB protocols.
- AND
- Have a diagnosis of uveitis, ocular inflammation, scleritis or a disease known to be associated with intraocular inflammation, (e.g., sarcoidosis, Beh(SqrRoot)(Beta)et s disease, multiple sclerosis (MS) and lymphoma or COVID-19 or other infections)
- OR
Key exclusion criteria (2 listed)
- 1. Patients without appropriate diagnostic and laboratory investigations for their diagnosis. Disease specific exclusion criteria will also be used. Patients will be excluded if appropriate laboratory investigations were not performed such as infectious serological tests and autoimmune labs. For posterior segment uveitis with retinal vasculitis, patients without fluorescein angiography will be excluded. Similarly, patients with choroiditis will be excluded if fundus autofluorescence studies were not performed. These disease specific exclusion criteria do not apply to healthy volunteers.
- Patients who were minors and NIH employees will be included in this retrospective study. The IRB approved protocols which these patients were managed under allow for the inclusion of these populations at time of original consent.
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
identify associations in laboratory markers
Time frame: at baseline
identify associations in laboratory markers with disease etiology
changes in ocular imaging findings
Time frame: pre- and post treatment
changes in ocular imaging findings including as OCT, OCTA, FA, ICG
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 19 Sep 2024.
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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.
Tiarnan DL Keenan, 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 and Ocular Inflammation, 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 8 inclusion and 2 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 19 Sep 2024. 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?
identify associations in laboratory markers (time frame: at baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Sep 2024.