drugset / Trial / NCT01256489
Infliximab to Improve Retention of the Boston Keratoprosthesis in Patients After Stevens Johnson Syndrome/ Toxic Epidermal Necrolysis (SJS/TENS)
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2010-12
- Primary completion
- 2015-01
- Completion
- 2015-01
Outcome
Outcome not reported
Stopped: “Steven Johnson's Syndrome (SJS) and Toxic Epidermal Necrolysis Syndrome (TENS) are rare (\~3 in 1 million). No eligible subjects have been identified.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Infliximab | Monoclonal antibody | 5 mg/kg | Intravenous |
| Subject | Infliximab | Monoclonal antibody | 10 mg/kg | Intravenous |