Infliximab to Treat Non-Infectious Scleritis
Scleritis
About this trial
This is an interventional treatment trial for Scleritis focused on measuring Infliximab, Scleritis, Intraocular Inflammatory Disease, Corticosteroids, Immunosuppressives
Eligibility Criteria
INCLUSION CRITERIA: To be eligible to enroll in this study, a prospective participant must satisfy the following inclusion criteria: Participant is 18 years of age or older. Participant has active non-infectious scleritis, diagnosed by a persistent congestion of deep episcleral vessels following a drop of 10% phenylephrine, without active intraocular inflammation. Participant has normal renal or liver function. Participant agrees to use acceptable birth control methods throughout the course of the study and for 6 months after completion of treatment. Participant has no evidence of tuberculosis as documented by tuberculin skin test performed prior to enrollment (chest x-ray, if medically indicated). Participant is able to understand and sign a consent form before entering the study. Participant has been treated with prednisone or other immunomodulatory medications but present with active disease at the time of enrollment. EXCLUSION CRITERIA: To be eligible to enroll in this study, a prospective participant must not satisfy any of the following exclusion criteria: Participant with a known underlying systemic disease with evidence of serious or potentially lethal uncontrolled active disease in one or more extraocular organ systems for which a defined effective medical regimen is indicated. Participant with a corneal melting, necrotizing keratitis, or impending vision loss. Participant with scleritis of infectious etiology. Participant receiving any other investigational therapy or another anti-TNF agent that would interfere with the ability to evaluate the safety or efficacy of infliximab. Participant has significant active infection requiring hospitalization. Participant with multiple sclerosis. Participant has severe (class 3/4) congestive heart failure. Participant has a history of cancer within the past 5 years other than basal or squamous cell carcinoma. Participant is pregnant or lactating as it is unknown whether infliximab is excreted in human milk or absorbed systemically after ingestion. Evidence of liver disease (any etiology).
Sites / Locations
- National Institutes of Health Clinical Center, 9000 Rockville Pike