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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: 17 November 2015
Main ID:  NCT01256489
Date of registration: 19/11/2010
Prospective Registration: Yes
Primary sponsor: Massachusetts Eye and Ear Infirmary
Public title: Infliximab to Improve Retention of the Boston Keratoprosthesis in Patients After Stevens Johnson Syndrome/ Toxic Epidermal Necrolysis (SJS/TENS)
Scientific title: Infliximab Therapy to Improve Retention of the Boston Keratoprosthesis in Patients After Stevens Johnson Syndrome/ Toxic Epidermal Necrolysis
Date of first enrolment: December 2010
Target sample size: 0
Recruitment status: Withdrawn
URL:  https://clinicaltrials.gov/show/NCT01256489
Study type:  Interventional
Study design:  Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment  
Phase:  Phase 1/Phase 2
Countries of recruitment
United States
Contacts
Name:     James Chodosh, MD, MPH
Address: 
Telephone:
Email:
Affiliation:  Massachusetts Eye and Ear Infirmary
Key inclusion & exclusion criteria

Inclusion Criteria:

- History of biopsy proven SJS/TENS with corneal opacity and neovascularization

- Bilateral legal blindness (<20/200 in better eye)

- 18 years of age or older

- Able to provide informed consent

- Sufficiently healthy to undergo infliximab infusions, surgery, and a vigorous
postoperative follow-up course

- Able to administer eye medications or have a care giver able and willing to do same

- Are considered eligible according to the following tuberculosis (TB) screening
criteria:

- Have no history of latent or active TB prior to screening.

- Have no signs or symptoms suggestive of active TB upon medical history and/or
physical examination.

- Have had no recent close contact with a person with active TB.

- Within 6 weeks prior to the first administration of study agent, have a negative
QuantiFERON-TB Gold test result (see Attachment A). Indeterminate results should
be handled as outlined in the Screening Visit Section. A negative tuberculin
skin test is considered acceptable if the QuantiFERON- TB Gold test is not
acceptable in that country.

- Have a chest radiograph (posterior-anterior view) taken within 3 months prior to
the first administration of study agent and read by a qualified radiologist,
with no evidence of current, active TB or old, inactive TB.

Exclusion Criteria:

- Visual acuity >20/200 in better eye

- Corneal blindness not due to effects of SJS/TENS

- Hypersensitivity to infliximab or chemically related medication

- Pregnant or lactating

- Have a history of latent or active granulomatous infection, including histoplasmosis
or coccidioidomycosis, prior to screening. Refer to inclusion criteria for
information regarding eligibility with a history of latent TB.

- Have had a Bacille Calmette-Guérin (BCG) vaccination within 12 months of screening.

- Have a chest radiograph within 3 months prior to the first administration of study
agent that shows an abnormality suggestive of a malignancy or current active
infection, including TB.

- Have had a nontuberculous mycobacterial infection or opportunistic infection (eg,
cytomegalovirus, pneumocystosis, aspergillosis) within 6 months prior to screening.

- Have indeterminate initial and repeat QuantiFERON-TB Gold test results.

- History or current diagnosis of diabetes mellitus

- History of immune system problem other than Stevens Johnson Syndrome

- History of recurrent infections

- History or current diagnosis of cancer

- Active psoriasis

- History of heart failure

- History of hepatitis B virus

- MRSA or VRE infection

- Nervous system disorders such as multiple sclerosis or Guillain-Barre syndrome

- Scheduled to receive a live vaccine at any time point during study participation

- Currently receiving treatments of Kineret (Anakinra)

- 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: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Corneal Blindness
Stevens-Johnson Syndrome
Intervention(s)
Drug: Infliximab
Primary Outcome(s)
Occurrence of corneal ulceration [Time Frame: Assessed monthly for up to 2 years following surgery]
Secondary Outcome(s)
Occurrence of systemic adverse events [Time Frame: Assessed monthly for up to 2 years following first infusion]
Period Of Prosthesis Retention [Time Frame: Assessed monthly for up to 2 years following surgery]
Vision Recovery [Time Frame: Assessed monthly for up to 2 years following surgery]
Secondary ID(s)
10-02-010
196405
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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