Topical Infliximab in Autoimmune Eyes With Keratoprosthesis
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|ClinicalTrials.gov Identifier: NCT02126020|
Recruitment Status : Withdrawn (No patients met eligibility criteria. The study has been closed.)
First Posted : April 29, 2014
Last Update Posted : April 7, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Stevens-Johnson Syndrome Toxic Epidermal Necrolysis (Lyell) Syndrome Mucous Membrane Pemphigoid||Drug: topical infliximab||Phase 1 Phase 2|
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 (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Topical Infliximab in Autoimmune Eyes With Keratoprosthesis|
|Study Start Date :||November 2014|
|Actual Primary Completion Date :||April 3, 2017|
|Estimated Study Completion Date :||April 3, 2017|
Experimental: topical infliximab
topical infliximab 10 mg/mL QID x 3 months followed by BID x 9 months
Drug: topical infliximab
topical infliximab administered QID for 3 months followed by BID for 9 months
Other Name: Remicade
- Tolerability [ Time Frame: 1 year ]Percentage of patients finishing 12 months of topical infliximab use
- Adverse events [ Time Frame: 2 years ]Number and type of adverse events
- rate of corneal melting [ Time Frame: 2 years ]rate of corneal melting or ulceration during infliximab prophylaxis (12 months) and after the drug is stopped (following 12 months)
- KPro retention [ Time Frame: 2 years ]Percentage of retained KPros at 2 years
- Visual acuity [ Time Frame: 2 years ]
- Ocular surface symptoms [ Time Frame: 2 years ]Ocular surface symptoms as assessed by ocular surface disease index score
- Ocular surface inflammation [ Time Frame: 2 years ]Ocular surface inflammation using slit-lamp photographs and the ocular redness index (ORI)
- tear matrix metalloproteinase (MMP) [ Time Frame: 2 years ]Levels and activity of MMPs, myeloperoxidase and tissue inhibitor of MMP-1
- graft thickness [ Time Frame: 2 years ]Corneal carrier graft thickness as measured by anterior segment optical coherence tomography before, during and after treatment with infliximab
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02126020
|United States, Massachusetts|
|Massachusetts Eye and Ear Infirmary|
|Boston, Massachusetts, United States, 02114|
|Centre Hospitalier de l'Université de Montréal|
|Montréal, Quebec, Canada, H2L 4M1|
|Principal Investigator:||James Chodosh, MD, MPH||Massachusetts Eye and Ear Infirmary|
|Study Chair:||Claes H Dohlman, MD, PhD||Massachusetts Eye and Ear Infirmary|
|Study Chair:||Mona Harissi-Dagher, MD||Centre hospitalier de l'Université de Montréal (CHUM)|