Status:
COMPLETED
Infliximab to Treat Non-Infectious Scleritis
Lead Sponsor:
National Eye Institute (NEI)
Conditions:
Scleritis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This small, preliminary study will examine whether multiple infusions of infliximab (Remicade® (Registered Trademark)) can control inflammation in patients with active scleritis. The sclera is the tou...
Detailed Description
We propose to investigate the possible efficacy of multiple infliximab infusions to control the inflammation in participants presenting with active scleritis. This will be performed using an open-labe...
Eligibility Criteria
Inclusion
- 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).
Exclusion
Key Trial Info
Start Date :
December 23 2003
Trial Type :
INTERVENTIONAL
End Date :
September 6 2007
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00075075
Start Date
December 23 2003
End Date
September 6 2007
Last Update
July 2 2017
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892