Recruitment

Recruitment Status
Withdrawn
Estimated Enrollment
4

Inclusion Criteria

Negative tuberculosis screening
Able to administer eye medications or have a care giver able and willing to do same
Age between 18 and 80 years
...
Negative tuberculosis screening
Able to administer eye medications or have a care giver able and willing to do same
Age between 18 and 80 years
Underlying diagnosis of SJS, TENS, or MMP
Able to provide informed consent
Implantation of a Boston KPro type I

Exclusion Criteria

History of Bacille Calmette-Guerin (BCG) vaccination within twelve months of screening
Unable to attend postoperative visits or administer medications, or no care giver available and willing to assist with same
Scheduled to receive a live vaccine at any time point during study participation
...
History of Bacille Calmette-Guerin (BCG) vaccination within twelve months of screening
Unable to attend postoperative visits or administer medications, or no care giver available and willing to assist with same
Scheduled to receive a live vaccine at any time point during study participation
Chest radiography, QuantiFERON-TB Gold or purified protein derivative (PPD) evidence of active or latent tuberculosis infection
Demyelinating disease
Heart failure (New York Heart Association class III or IV)
KPro designs with less than 16 holes in the back plate (to avoid the confounder of corneal nutrition)
Pregnancy or breast-feeding
Allergy to infliximab or any of the compounds in its topical formulation or any chemically-related medication
Malignancy diagnosed in the last five years
Indeterminate initial and repeat QuantiFERON-TB Gold results
history of hepatitis B virus
Methicillin resistant Staphylococcus aureus (MRSA) or vancomycin resistant enterococcus (VRE) infection
History of latent or active granulomatous infection, including histoplasmosis or coccidioidomycosis, prior to screening
History of a nontuberculous mycobacterial infection or opportunistic infection (e.g. cytomegalovirus, pneumocystosis, aspergillosis) within six months prior to screening
Chest radiograph within three months prior to the first administration of the study drug that shows an abnormality suggestive of a malignancy or current active infection, including tuberculosis.
Prior or current use of systemic anti-tumor necrosis alpha-α medications or currently receiving treatments of Kineret (Anakinra)
Inability to comply with the instillation of additional drops
History or current diagnosis of diabetes mellitus (controlled and uncontrolled)

Summary

Conditions
  • Mucous Membrane Pemphigoid
  • Stevens - Johnson Syndrome
  • Toxic Epidermal Necrolysis (Lyell) Syndrome
  • Stevens-Johnson Syndrome
Type
Interventional
Phase
Phase 1Phase 2
Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Prevention

Participation Requirements

Age
Between 18 years and 80 years
Gender
Both males and females

Description

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 ...

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.

Inclusion Criteria

Negative tuberculosis screening
Able to administer eye medications or have a care giver able and willing to do same
Age between 18 and 80 years
...
Negative tuberculosis screening
Able to administer eye medications or have a care giver able and willing to do same
Age between 18 and 80 years
Underlying diagnosis of SJS, TENS, or MMP
Able to provide informed consent
Implantation of a Boston KPro type I

Exclusion Criteria

History of Bacille Calmette-Guerin (BCG) vaccination within twelve months of screening
Unable to attend postoperative visits or administer medications, or no care giver available and willing to assist with same
Scheduled to receive a live vaccine at any time point during study participation
...
History of Bacille Calmette-Guerin (BCG) vaccination within twelve months of screening
Unable to attend postoperative visits or administer medications, or no care giver available and willing to assist with same
Scheduled to receive a live vaccine at any time point during study participation
Chest radiography, QuantiFERON-TB Gold or purified protein derivative (PPD) evidence of active or latent tuberculosis infection
Demyelinating disease
Heart failure (New York Heart Association class III or IV)
KPro designs with less than 16 holes in the back plate (to avoid the confounder of corneal nutrition)
Pregnancy or breast-feeding
Allergy to infliximab or any of the compounds in its topical formulation or any chemically-related medication
Malignancy diagnosed in the last five years
Indeterminate initial and repeat QuantiFERON-TB Gold results
history of hepatitis B virus
Methicillin resistant Staphylococcus aureus (MRSA) or vancomycin resistant enterococcus (VRE) infection
History of latent or active granulomatous infection, including histoplasmosis or coccidioidomycosis, prior to screening
History of a nontuberculous mycobacterial infection or opportunistic infection (e.g. cytomegalovirus, pneumocystosis, aspergillosis) within six months prior to screening
Chest radiograph within three months prior to the first administration of the study drug that shows an abnormality suggestive of a malignancy or current active infection, including tuberculosis.
Prior or current use of systemic anti-tumor necrosis alpha-α medications or currently receiving treatments of Kineret (Anakinra)
Inability to comply with the instillation of additional drops
History or current diagnosis of diabetes mellitus (controlled and uncontrolled)

Tracking Information

NCT #
NCT02126020
Collaborators
  • Massachusetts Eye and Ear Infirmary
  • Fonds de recherche en ophtalmologie de l'Université de Montréal
Investigators
  • 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)
  • 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)
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