Brief Title
Topical Infliximab in Autoimmune Eyes With Keratoprosthesis
Official Title
Topical Infliximab in Autoimmune Eyes With Keratoprosthesis
Brief Summary
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.
Detailed 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 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 Phase
Phase 1/Phase 2
Study Type
Interventional
Primary Outcome
Tolerability
Secondary Outcome
Visual acuity
Condition
Stevens-Johnson Syndrome
Intervention
topical infliximab
Study Arms / Comparison Groups
topical infliximab
Description: topical infliximab 10 mg/mL QID x 3 months followed by BID x 9 months
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
0
Start Date
November 2014
Completion Date
April 3, 2017
Primary Completion Date
April 3, 2017
Eligibility Criteria
Inclusion Criteria:
- Age between 18 and 80 years
- Able to provide informed consent
- 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
- Negative tuberculosis screening
Exclusion Criteria:
- Active or recurrent ocular or systemic infection
- Chest radiography, QuantiFERON-TB Gold or purified protein derivative (PPD)
evidence of active or latent tuberculosis infection
- Indeterminate initial and repeat QuantiFERON-TB Gold results
- 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.
- History of a nontuberculous mycobacterial infection or opportunistic infection
(e.g. cytomegalovirus, pneumocystosis, aspergillosis) within six months prior to
screening
- history of hepatitis B virus
- Methicillin resistant Staphylococcus aureus (MRSA) or vancomycin resistant
enterococcus (VRE) infection
- Malignancy diagnosed in the last five years
- Demyelinating disease
- History or current diagnosis of diabetes mellitus (controlled and uncontrolled)
- Heart failure (New York Heart Association class III or IV)
- Pregnancy or breast-feeding
- Scheduled to receive a live vaccine at any time point during study participation
- Allergy to infliximab or any of the compounds in its topical formulation or any
chemically-related medication
- Prior or current use of systemic anti-tumor necrosis alpha-α medications or currently
receiving treatments of Kineret (Anakinra)
- KPro designs with less than 16 holes in the back plate (to avoid the confounder of
corneal nutrition)
- Inability to comply with the instillation of additional drops
- Unable to attend postoperative visits or administer medications, or no care giver
available and willing to assist with same
Gender
All
Ages
18 Years - 80 Years
Accepts Healthy Volunteers
No
Contacts
James Chodosh, MD, MPH, ,
Location Countries
Canada
Location Countries
Canada
Administrative Informations
NCT ID
NCT02126020
Organization ID
MEEI 13-110H
Secondary IDs
IND 122719
Responsible Party
Sponsor-Investigator
Study Sponsor
James Chodosh, MD, MPH
Collaborators
Massachusetts Eye and Ear Infirmary
Study Sponsor
James Chodosh, MD, MPH, Principal Investigator, Massachusetts Eye and Ear Infirmary
Verification Date
April 2017