Study Stopped
No patients met eligibility criteria. The study has been closed.
Sponsor study identifier
Secondary identifiers
OTHER · FDA
interventional
0
2 countries
2
Study Start
November 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 3, 2017
Actual (reported)Study Completion
April 3, 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 3, 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 27, 2014
Actual (reported)April 29, 2014
Actual (reported)November 2014
Date type not reportedThis date has not been verified as actual or estimated.
April 3, 2017
Actual (reported)April 3, 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Tolerability
Percentage of patients finishing 12 months of topical infliximab use
1 year
Adverse events
Number and type of adverse events
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)
2 years
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
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, 02114, United States
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, H2L 4M1, Canada
James Chodosh, MD, MPH
Massachusetts Eye and Ear Infirmary
Claes H Dohlman, MD, PhD
Massachusetts Eye and Ear Infirmary
Mona Harissi-Dagher, MD
Centre hospitalier de l'Université de Montréal (CHUM)
0 participants (actual enrollment reported by the registry).
First Submitted
April 27, 2014
First Posted
April 29, 2014
Study Start
November 2014
Date type not reportedThis date has not been verified as actual or estimated.
KPro retention
Percentage of retained KPros at 2 years
2 years
Visual acuity
2 years
Ocular surface symptoms
2 years
Ocular surface inflammation
2 years
tear matrix metalloproteinase (MMP)
2 years
graft thickness
2 years
Contact the study team to confirm eligibility.
Primary Completion
April 3, 2017
Actual (reported)Study Completion
April 3, 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
April 7, 2017
Record last verified: 2017-04
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Source: ClinicalTrials.gov.
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