Stevens-Johnson Syndrome Clinical Trial
Official title:
Topical Infliximab in Autoimmune Eyes With Keratoprosthesis
The Boston Keratoprosthesis type I (KPro) is a prosthetic cornea used to treat several
causes of corneal blindness. Some categories of patients, including those with auto-immune
diseases such as Stevens-Johnson syndrome, toxic epidermal necrolysis syndrome and mucous
membrane pemphigoid, have a higher risk of failure for the KPro. Because of chronic
inflammation, the cornea supporting the KPro may melt, leading to a higher risk of
infection, loss of the KPro and loss of the eye.
Infliximab is an antibody against tumor necrosis factor alpha and is used intravenously to
control inflammation in several diseases. It has been used in some cases of corneal melting
with significant success.
This study's hypothesis is that infliximab can be successfully used as an eye drop (instead
of the usual administration through veins) and that its regular use may prevent melt in eyes
with a Boston Keratoprosthesis type I and underlying auto-immune disease.
This is an unmasked, prospective, multicenter clinical trial of four patients that are
candidates for a Boston Keratoprosthesis or have had prior KPro surgery and have a diagnosis
of Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis syndrome (TENS) or mucous
membrane pemphigoid (MMP). Only one eye per patient will be considered for inclusion.
This is a phase I/II study to evaluate the safety and tolerance of topical infliximab 10
mg/mL eye drops. Research subjects will be required to administer infliximab eye drops four
times per day for three months followed by twice daily administration for nine months. The
subjects will be monitored while on the study medication as well as for one year following
discontinuation of the drug. The total study duration for each patient will be two years.
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