Infliximab to Improve Retention of the Boston Keratoprosthesis in Patients After Stevens Johnson … (NCT01256489) | Clinical Trial Compass
WithdrawnPhase 1/2
Infliximab to Improve Retention of the Boston Keratoprosthesis in Patients After Stevens Johnson Syndrome/ Toxic Epidermal Necrolysis (SJS/TENS)
Stopped: Steven Johnson's Syndrome (SJS) and Toxic Epidermal Necrolysis Syndrome (TENS) are rare (\~3 in 1 million). No eligible subjects have been identified.
United States0Started 2010-12
Plain-language summary
The proposed study is intended to test the idea, based upon current knowledge of the biology and physiology of corneal ulceration in SJS/TENS patients who receive a keratoprosthesis, and on the known effects of infliximab on matrix metalloproteinases, that infliximab therapy for such patients may reduce the likelihood of corneal ulceration, and hence extend the period of prosthesis retention and vision recovery.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* History of biopsy proven SJS/TENS with corneal opacity and neovascularization
* Bilateral legal blindness (\<20/200 in better eye)
* 18 years of age or older
* Able to provide informed consent
* Sufficiently healthy to undergo infliximab infusions, surgery, and a vigorous postoperative follow-up course
* Able to administer eye medications or have a care giver able and willing to do same
* Are considered eligible according to the following tuberculosis (TB) screening criteria:
* Have no history of latent or active TB prior to screening.
* Have no signs or symptoms suggestive of active TB upon medical history and/or physical examination.
* Have had no recent close contact with a person with active TB.
* Within 6 weeks prior to the first administration of study agent, have a negative QuantiFERON-TB Gold test result (see Attachment A). Indeterminate results should be handled as outlined in the Screening Visit Section. A negative tuberculin skin test is considered acceptable if the QuantiFERON- TB Gold test is not acceptable in that country.
* Have a chest radiograph (posterior-anterior view) taken within 3 months prior to the first administration of study agent and read by a qualified radiologist, with no evidence of current, active TB or old, inactive TB.
Exclusion Criteria:
* Visual acuity \>20/200 in better eye
* Corneal blindness not due to effects of SJS/TENS
* Hypersensitivity to infliximab or chemically related medication
* Pregnant or l…
What they're measuring
1
Occurrence of corneal ulceration
Timeframe: Assessed monthly for up to 2 years following surgery