Advertisement

Topics

Topical Infliximab in Autoimmune Eyes With Keratoprosthesis

2014-11-06 00:53:22 | BioPortfolio

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.

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Conditions

Stevens-Johnson Syndrome

Intervention

topical infliximab

Location

Centre Hospitalier de l'Université de Montréal
Montréal
Quebec
Canada
H2L 4M1

Status

Enrolling by invitation

Source

Massachusetts Eye and Ear Infirmary

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-11-06T00:53:22-0500

Clinical Trials [1693 Associated Clinical Trials listed on BioPortfolio]

Phase III Clinical Trial of NPB-01 in Patients With Stevens-Johnson Syndrome/ Toxic Epidermal Necrolysis Unresponsive to Corticosteroids.

Patients diagnosed with Stevens-Johnson syndrome and Toxic Epidermal Necrolysis were confirmed based on the investigators national diagnostic criteria. Patients who meet all inclusion crit...

Stevens-Johnson Syndrome Antimicrobial

Steven-Johnson's syndrome, or great multiform erythema, appears as a systemic disturbance, with skin involvement and mucous membranes, related to several factors, such as, viral or bacteri...

Topical Infliximab for Sterile Corneal Melt

Corneal melt is a complication that could affect very ill eyes and lead to the thinning of the cornea (the clear window covering of the eyes). This thinning can lead to severe consequences...

Corneal Epitheliotropic Factors in Autologous Serum Eye Drops in Nonautoimmune and Stevens-Johnson Syndrome With Dry Eye

Autologous serum eye drops (ASE) have been becoming popular in treatment of severe dry eye for the past decade. One of the most beneficial properties of the ASE over artificial eye drops ...

Cyclosporine and Etanercept in Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis

Defining the true effect of adjunctive therapy for Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis (SJS/TEN) on time to full healing, mortality, and long-term outcomes represents a...

PubMed Articles [5346 Associated PubMed Articles listed on BioPortfolio]

Bronchiolitis Obliterans After Cefuroxime-Induced Stevens-Johnson Syndrome.

BACKGROUND Bronchiolitis obliterans is the term used to describe a clinical syndrome of irreversible airflow obstruction. Among the etiologies linked to this entity is the rarely reported association ...

Stevens-Johnson syndrome and toxic epidermal necrolysis: retrospective review of 10-year experience.

Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) are severe mucocutaneous disorders. To date, relatively few studies have looked at institutional approaches to treatment of SJS/TEN,...

Multi-Step Grading System for Evaluation of Chronic Ocular Sequelae in Patients with Stevens-Johnson Syndrome.

To propose a new scoring system for grading of chronic ocular sequelae in Stevens-Johnson syndrome (SJS).

Fluoxetine-induced Stevens-Johnson syndrome and liver injury.

Drug-induced liver injuries (DILI) are overall rare and often associated with use of medications. Medications are also the most common aetiology of Stevens-Johnson syndrome (SJS), but SJS is seldom se...

Corneal limbal stem cell deficiency in children with Stevens-Johnson syndrome.

To determine the incidence of corneal limbal stem cell deficiency (LSCD) as chronic ocular sequelae in children with Stevens-Johnson syndrome (SJS) / toxic epidermal necrolysis (TEN) and analyze the f...

Medical and Biotech [MESH] Definitions

A variant of bullous erythema multiforme. It ranges from mild skin and mucous membrane lesions to a severe, sometimes fatal systemic disorder. Ocular symptoms include ulcerative conjunctivitis, keratitis, iritis, uveitis, and sometimes blindness. The cause of the disease is unknown.

Fluorides, usually in pastes or gels, used for topical application to reduce the incidence of DENTAL CARIES.

A chimeric monoclonal antibody to TNF ALPHA that is used in the treatment of RHEUMATOID ARTHRITIS; ANKYLOSING SPONDYLITIS; PSORIATIC ARTHRITIS and CROHN'S DISEASE.

Sodium or potassium salts of long chain fatty acids. These detergent substances are obtained by boiling natural oils or fats with caustic alkali. Sodium soaps are harder and are used as topical anti-infectives and vehicles in pills and liniments; potassium soaps are soft, used as vehicles for ointments and also as topical antimicrobials.

Condition with a variable constellation of phenotypes due to deletion polymorphisms at chromosome location 22q11. It encompasses several syndromes with overlapping abnormalities including the DIGEORGE SYNDROME, VELOCARDIOFACIAL SYNDROME, and CONOTRUNCAL AMOMALY FACE SYNDROME. In addition, variable developmental problems and schizoid features are also associated with this syndrome. (From BMC Med Genet. 2009 Feb 25;10:16) Not all deletions at 22q11 result in the 22q11deletion syndrome.

More From BioPortfolio on "Topical Infliximab in Autoimmune Eyes With Keratoprosthesis"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Ophthalmology
Ophthalmology is the branch of medicine that is devoted to the study and treatment of eye diseases. As well as mild visual defects correctable by lenses, ophthalmology is concerned with glaucoma, uveitis and other serious conditions affecting the eye, ...

Infectious-diseases
Antiretroviral Therapy Clostridium Difficile Ebola HIV & AIDS Infectious Diseases Influenza Malaria Measles Sepsis Swine Flu Tropical Medicine Tuberculosis Infectious diseases are caused by pathogenic...


Searches Linking to this Trial