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All Drugs and Chemicals

Infliximab

Tumor Necrosis Factor Inhibitors

topical infliximab 10 mg/mL QID x 3 months followed by BID x 9 months

topical infliximab administered QID for 3 months followed by BID for 9 months

topical infliximab

James Chodosh, MD, MPH

Claes H Dohlman, MD, PhD

Mona Harissi-Dagher, MD

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.

Topical Infliximab in Autoimmune Eyes With Keratoprosthesis

Percentage of patients finishing 12 months of topical infliximab use

rate of corneal melting or ulceration during infliximab prophylaxis (12 months) and after the drug is stopped (following 12 months)

Ocular surface symptoms as assessed by ocular surface disease index score

Ocular surface inflammation using slit-lamp photographs and the ocular redness index (ORI)

Levels and activity of MMPs, myeloperoxidase and tissue inhibitor of MMP-1

Corneal carrier graft thickness as measured by anterior segment optical coherence tomography before, during and after treatment with infliximab

Massachusetts Eye and Ear Infirmary

Fonds de recherche en ophtalmologie de l'Université de Montréal

Associate Director of the Cornea and Refractive Surgery Service, Director of Boston Keratoprosthesis Clinical Programs

Spots Global Cancer Trial Database for keratolysis

Every month we try and update this database with for keratolysis cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for keratolysis

Every month we try and update this database with for keratolysis cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for keratolysis cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.