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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
topical infliximab administered QID for 3 months followed by BID for 9 months
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, United States
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, Canada
Tolerability
Percentage of patients finishing 12 months of topical infliximab use
Time frame: 1 year
Adverse events
Number and type of adverse events
Time frame: 2 years
rate of corneal melting
rate of corneal melting or ulceration during infliximab prophylaxis (12 months) and after the drug is stopped (following 12 months)
Time frame: 2 years
KPro retention
Percentage of retained KPros at 2 years
Time frame: 2 years
Visual acuity
Time frame: 2 years
Ocular surface symptoms
Ocular surface symptoms as assessed by ocular surface disease index score
Time frame: 2 years
Ocular surface inflammation
Ocular surface inflammation using slit-lamp photographs and the ocular redness index (ORI)
Time frame: 2 years
tear matrix metalloproteinase (MMP)
Levels and activity of MMPs, myeloperoxidase and tissue inhibitor of MMP-1
Time frame: 2 years
graft thickness
Corneal carrier graft thickness as measured by anterior segment optical coherence tomography before, during and after treatment with infliximab
Time frame: 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.