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 range
18 Years
Sex
ALL
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Occurrence of corneal ulceration
Timeframe: Assessed monthly for up to 2 years following surgery