Infliximab to Improve Retention of the Boston Keratoprosthesis in Patients After Stevens Johnson Syndrome/ Toxic Epidermal Necrolysis (SJS/TENS)

• Status: Withdrawn
• Trial end date: 2015-01-01
• Target enrollment: 0
• Participant gender: All

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 effects of infliximab on matrix metalloproteinases, that infliximab therapy for such patients may reduce the likelihood of corneal ulceration, and hence extend the period of prosthesis retention and vision recovery.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts Eye and Ear Infirmary
• Treatments: Infliximab

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