Uveitis Clinical Trial - Biomarkers in Ocular Inflammation & Uveitis

Status Completed

Clinical 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. 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04690829
Study type	Observational
Source	National Institutes of Health Clinical Center (CC)
Contact
Status	Completed
Phase
Start date	December 29, 2020
Completion date	November 16, 2022

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04101604` - Biomarkers of Common Eye Diseases
Active, not recruiting	`NCT04704609` - Imaging Quantification of Inflammation (IQI)
Completed	`NCT03173144` - Chronic Inflammatory Disease, Lifestyle and Treatment Response
Withdrawn	`NCT01280669` - Intravitreal Sirolimus as Therapeutic Approach to Uveitis	Phase 2
Terminated	`NCT02907814` - Measurement of Anterior Chamber Cell Grading Using Ocular Coherence Tomography	N/A
Active, not recruiting	`NCT02252328` - Use of Simvastatin as a Steroid Sparing Agent for Uveitis Patients	Phase 2/Phase 3
Completed	`NCT04183387` - Simvastatin in Uveitis	Phase 2
Completed	`NCT01983488` - Clinical Outcome in Uveitis
Withdrawn	`NCT00499551` - A Phase I/IIa Study for the Treatment of Uveitis With Iontophoresis	Phase 1/Phase 2
Terminated	`NCT00114062` - Study to Treat Uveitis Associated Macular Edema	Phase 2
Completed	`NCT00132691` - Multicenter Uveitis Steroid Treatment (MUST) Trial	Phase 4
Completed	`NCT00476593` - Retinal OCT and (mfERG) Related to Age, Sex, and the Use of Anti-inflammatory Medications	N/A
Completed	`NCT00001867` - Effect of Pregnancy on Uveitis	N/A
Completed	`NCT00379275` - Eye and Immunogenetic Features of Sarcoidosis	N/A
Active, not recruiting	`NCT03828019` - Adalimumab vs. Conventional Immunosuppression for Uveitis Trial	Phase 3
Terminated	`NCT01939691` - Macular Edema Nepafenac vs. Difluprednate Uveitis Trial	Phase 4
Active, not recruiting	`NCT03889860` - Objective Choroidal Thickness Measurements in Uveitis
Completed	`NCT00070759` - Daclizumab to Treat Non-Infectious Sight-Threatening Uveitis	Phase 2
Recruiting	`NCT05486468` - The Use of Two YUTIQ Versus Sham for Treatment of Chronic Non Infectious Intraocular Inflammation Affecting the Posterior Segment	Phase 3
Active, not recruiting	`NCT05385757` - UNICORNS: Uveitis in Childhood Prospective National Cohort Study

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Biomarkers in Ocular Inflammation and Uveitis

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms