Clinical Trials Logo

Clinical Trial Summary

The Boston Keratoprosthesis type I (KPro) is a prosthetic cornea used to treat several causes of corneal blindness. Some categories of patients, including those with auto-immune diseases such as Stevens-Johnson syndrome, toxic epidermal necrolysis syndrome and mucous membrane pemphigoid, have a higher risk of failure for the KPro. Because of chronic inflammation, the cornea supporting the KPro may melt, leading to a higher risk of infection, loss of the KPro and loss of the eye.

Infliximab is an antibody against tumor necrosis factor alpha and is used intravenously to control inflammation in several diseases. It has been used in some cases of corneal melting with significant success.

This study's hypothesis is that infliximab can be successfully used as an eye drop (instead of the usual administration through veins) and that its regular use may prevent melt in eyes with a Boston Keratoprosthesis type I and underlying auto-immune disease.


Clinical Trial Description

This is an unmasked, prospective, multicenter clinical trial of four patients that are candidates for a Boston Keratoprosthesis or have had prior KPro surgery and have a diagnosis of Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis syndrome (TENS) or mucous membrane pemphigoid (MMP). Only one eye per patient will be considered for inclusion.

This is a phase I/II study to evaluate the safety and tolerance of topical infliximab 10 mg/mL eye drops. Research subjects will be required to administer infliximab eye drops four times per day for three months followed by twice daily administration for nine months. The subjects will be monitored while on the study medication as well as for one year following discontinuation of the drug. The total study duration for each patient will be two years. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02126020
Study type Interventional
Source Massachusetts Eye and Ear Infirmary
Contact
Status Withdrawn
Phase Phase 1/Phase 2
Start date November 2014
Completion date April 3, 2017

See also
  Status Clinical Trial Phase
Recruiting NCT03659227 - Drug Reactions Sampling (COLLECTIONTOXIDERMIES)
Completed NCT01696500 - Phase III Clinical Trial of NPB-01 in Patients With Stevens-Johnson Syndrome/ Toxic Epidermal Necrolysis Unresponsive to Corticosteroids. Phase 3
Terminated NCT02037347 - Study to Evaluate the Use of Palifermin to Treat Toxic Epidermal Necrolysis Phase 1/Phase 2
Active, not recruiting NCT05520086 - Clinical Trial to Evaluate Safety and Efficacy of Cell Therapy in Patients With Cicatricial Conjuntivitis. Phase 1/Phase 2
Completed NCT06263140 - Vitamin D Levels in Non-immediate Drug Hypersensitivity Case-control Study
Available NCT02149732 - Clinical Trial on the Effect of Autologous Oral Mucosal Epithelial Sheet Transplantation Phase 1/Phase 2
Recruiting NCT05284929 - Human Leukocyte Antigen Class II (DRB1 and DQB1) Alleles and Haplotypes Frequencies in Patients With Pemphigus Vulgaris Among the Russian Population
Recruiting NCT02987257 - NATIENS: Optimal Management and Mechanisms of SJS/TEN Phase 3
Completed NCT02945176 - Safety and Performance Study of the ARGOS-IO System in Patients Undergoing Boston Keratoprosthesis Implantation N/A
Not yet recruiting NCT03585946 - Outcomes in Stevens Johnsons Syndrome and Toxic Epidermal Necrolysis
Recruiting NCT04313725 - Evaluation of Tangible Boost for Patients With Stevens Johnson Syndrome, Sjogren's Syndrome, and Graft Vs Host Disease N/A
Recruiting NCT03046914 - HLA-B*5801 Screening to Prevent Allopurinol-induced Severe Cutaneous Adverse Reaction N/A
Completed NCT01488396 - Efficacy of 0.05% Cyclosporin Eye Drop in Stevens Johnson Syndrome Patient With Chronic Dry Eye Phase 4
Withdrawn NCT01256489 - Infliximab to Improve Retention of the Boston Keratoprosthesis in Patients After Stevens Johnson Syndrome/ Toxic Epidermal Necrolysis (SJS/TENS) Phase 1/Phase 2
Active, not recruiting NCT01122303 - Corneal Epitheliotropic Factors in Autologous Serum Eye Drops in Nonautoimmune and Stevens-Johnson Syndrome With Dry Eye N/A
Recruiting NCT05145959 - Meibomian Gland Probing in the Sub-Acute Phase of Patients With Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis N/A
Completed NCT00844038 - Stevens-Johnson Syndrome Antimicrobial N/A