Status:
WITHDRAWN
Infliximab to Improve Retention of the Boston Keratoprosthesis in Patients After Stevens Johnson Syndrome/ Toxic Epidermal Necrolysis (SJS/TENS)
Lead Sponsor:
Massachusetts Eye and Ear Infirmary
Conditions:
Stevens-Johnson Syndrome
Corneal Blindness
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The proposed study is intended to test the idea, based upon current knowledge of the biology and physiology of corneal ulceration in SJS/TENS patients who receive a keratoprosthesis, and on the known ...
Detailed Description
The closely related disorders, Stevens Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis Syndrome (TENS), represent rare but severe hypersensitivity responses to a systemic medication, and cause s...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01256489
Start Date
December 1 2010
End Date
January 1 2015
Last Update
November 4 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, United States, 02114