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.
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
Yes |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Observational |
Eligible Ages | 8 Years and Over |
Gender | All |
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT02656381 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
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Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
National Eye Institute (NEI) |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Shilpa M Kodati, M.D. |
Principal Investigator Affiliation | National Eye Institute (NEI) |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
NIH |
Overall Status | Recruiting |
Countries | United States |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Uveitis |
Study Website: | View Trial Website |
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