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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 16 December 2017
Main ID:  NCT02126020
Date of registration: 27/04/2014
Prospective Registration: Yes
Primary sponsor: James Chodosh, MD, MPH
Public title: Topical Infliximab in Autoimmune Eyes With Keratoprosthesis
Scientific title: Topical Infliximab in Autoimmune Eyes With Keratoprosthesis
Date of first enrolment: November 2014
Target sample size: 0
Recruitment status: Withdrawn
URL:  https://clinicaltrials.gov/show/NCT02126020
Study type:  Interventional
Study design:  Intervention model: Single Group Assignment. Primary purpose: Prevention. Masking: None (Open Label).  
Phase:  Phase 1/Phase 2
Countries of recruitment
Canada United States
Contacts
Name:     Mona Harissi-Dagher, MD
Address: 
Telephone:
Email:
Affiliation:  Centre hospitalier de l'Université de Montréal (CHUM)
Name:     Claes H Dohlman, MD, PhD
Address: 
Telephone:
Email:
Affiliation:  Massachusetts Eye and Ear Infirmary
Name:     James Chodosh, MD, MPH
Address: 
Telephone:
Email:
Affiliation:  Massachusetts Eye and Ear Infirmary
Key inclusion & exclusion 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-a 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



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All
Health Condition(s) or Problem(s) studied
Mucous Membrane Pemphigoid
Stevens-Johnson Syndrome
Toxic Epidermal Necrolysis (Lyell) Syndrome
Intervention(s)
Drug: topical infliximab
Primary Outcome(s)
Adverse events [Time Frame: 2 years]
KPro retention [Time Frame: 2 years]
rate of corneal melting [Time Frame: 2 years]
Tolerability [Time Frame: 1 year]
Secondary Outcome(s)
graft thickness [Time Frame: 2 years]
Ocular surface inflammation [Time Frame: 2 years]
Ocular surface symptoms [Time Frame: 2 years]
tear matrix metalloproteinase (MMP) [Time Frame: 2 years]
Visual acuity [Time Frame: 2 years]
Secondary ID(s)
IND 122719
MEEI 13-110H
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Fonds de recherche en ophtalmologie de l'Université de Montréal (FROUM)
Massachusetts Eye and Ear Infirmary
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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