Topical Infliximab in Autoimmune Eyes With Keratoprosthesis
Last updated on April 2022Recruitment
- Recruitment Status
- Withdrawn
- Estimated Enrollment
- 4
Inclusion Criteria
- Age between 18 and 80 years
- Able to provide informed consent
- Negative tuberculosis screening
- ...
- Age between 18 and 80 years
- Able to provide informed consent
- Negative tuberculosis screening
- Underlying diagnosis of SJS, TENS, or MMP
- Implantation of a Boston KPro type I
- Able to administer eye medications or have a care giver able and willing to do same
Exclusion Criteria
- Heart failure (New York Heart Association class III or IV)
- Malignancy diagnosed in the last five years
- History or current diagnosis of diabetes mellitus (controlled and uncontrolled)
- ...
- Heart failure (New York Heart Association class III or IV)
- Malignancy diagnosed in the last five years
- History or current diagnosis of diabetes mellitus (controlled and uncontrolled)
- History of Bacille Calmette-Guerin (BCG) vaccination within twelve months of screening
- History of latent or active granulomatous infection, including histoplasmosis or coccidioidomycosis, 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.
- Chest radiography, QuantiFERON-TB Gold or purified protein derivative (PPD) evidence of active or latent tuberculosis infection
- Pregnancy or breast-feeding
- Demyelinating disease
- Indeterminate initial and repeat QuantiFERON-TB Gold results
- history of hepatitis B virus
- Scheduled to receive a live vaccine at any time point during study participation
- History of a nontuberculous mycobacterial infection or opportunistic infection (e.g. cytomegalovirus, pneumocystosis, aspergillosis) within six months prior to screening
- Unable to attend postoperative visits or administer medications, or no care giver available and willing to assist with same
- Allergy to infliximab or any of the compounds in its topical formulation or any chemically-related medication
- Methicillin resistant Staphylococcus aureus (MRSA) or vancomycin resistant enterococcus (VRE) infection
- KPro designs with less than 16 holes in the back plate (to avoid the confounder of corneal nutrition)
- 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
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
- Age between 18 and 80 years
- Able to provide informed consent
- Negative tuberculosis screening
- ...
- Age between 18 and 80 years
- Able to provide informed consent
- Negative tuberculosis screening
- Underlying diagnosis of SJS, TENS, or MMP
- Implantation of a Boston KPro type I
- Able to administer eye medications or have a care giver able and willing to do same
Exclusion Criteria
- Heart failure (New York Heart Association class III or IV)
- Malignancy diagnosed in the last five years
- History or current diagnosis of diabetes mellitus (controlled and uncontrolled)
- ...
- Heart failure (New York Heart Association class III or IV)
- Malignancy diagnosed in the last five years
- History or current diagnosis of diabetes mellitus (controlled and uncontrolled)
- History of Bacille Calmette-Guerin (BCG) vaccination within twelve months of screening
- History of latent or active granulomatous infection, including histoplasmosis or coccidioidomycosis, 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.
- Chest radiography, QuantiFERON-TB Gold or purified protein derivative (PPD) evidence of active or latent tuberculosis infection
- Pregnancy or breast-feeding
- Demyelinating disease
- Indeterminate initial and repeat QuantiFERON-TB Gold results
- history of hepatitis B virus
- Scheduled to receive a live vaccine at any time point during study participation
- History of a nontuberculous mycobacterial infection or opportunistic infection (e.g. cytomegalovirus, pneumocystosis, aspergillosis) within six months prior to screening
- Unable to attend postoperative visits or administer medications, or no care giver available and willing to assist with same
- Allergy to infliximab or any of the compounds in its topical formulation or any chemically-related medication
- Methicillin resistant Staphylococcus aureus (MRSA) or vancomycin resistant enterococcus (VRE) infection
- KPro designs with less than 16 holes in the back plate (to avoid the confounder of corneal nutrition)
- 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
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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