Advertisement

Topics

Myfortic for the Treatment of Non-infectious Intermediate Uveitis

2014-08-27 03:14:59 | BioPortfolio

Summary

The objective of this clinical trial is to evaluate the efficacy, safety and tolerability of enteric-coated mycophenolate sodium (Myfortic®) in combination with low-dose corticosteroids (Decortin H®) compared to a monotherapy with low-dose corticosteroids (Decortin H®) in subjects with chronic intraocular inflammation (non-infectious intermediate uveitis).

Description

Mycophenolate mofetil (MMF), a pro-drug containing mycophenolic acid (MPA) as active agent, is approved for the treatment of acute graft rejection after kidney-, heart- and liver-transplantation, and was shown in 1995 to be effective in inhibiting the development of experimental autoimmune uveoretinitis. Further studies proved it to be a safe and effective steroid-sparing immunomodulatory for reducing the recurrence rate of non-infectious intermediate uveitis in humans. Although the adverse effect profile of MMF is comparatively benign, gastrointestinal adverse effects are a major concern and may limit its clinical benefit, because they may necessitate dose reduction, interruption, or even discontinuation of MMF.

An enteric-coated formulation of mycophenolate sodium (EC-MPS, Myfortic) has been developed especially to reduce MPA-related gastrointestinal adverse events. This clinical trial is a prospective controlled study to evaluate whether a Myfortic based regimen will be able to reduce the probability of a relapse compared to steroid therapy alone and to test whether a Myfortic based therapy provides a superior behaviour compared to a steroid regimen.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Non-infectious Intermediate Uveitis

Intervention

Myfortic, Decortin

Location

Charité Universitätsmedizin Berlin, Augenklinik
Berlin
Germany
13353

Status

Recruiting

Source

STZ eyetrial

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:14:59-0400

Clinical Trials [427 Associated Clinical Trials listed on BioPortfolio]

HUMIRA® Long-term Treatment in Patients With Non-infectious Intermediate-, Posterior-, or Pan-uveitis

This study evaluates the long- term safety and effectiveness of adalimumab in participants with non-infectious intermediate-, posterior-, or pan-uveitis in daily practice in Japan.

A Study of the Long-term Safety and Efficacy of Adalimumab in Subjects With Intermediate-, Posterior-, or Pan-uveitis

There is an unmet medical need in non-infectious intermediate-, posterior- and pan uveitis. These types of uveitis are at a higher risk for vision loss compared to anterior uveitis. Patien...

A Study of the Safety and Efficacy of a New Treatment for Non-Infectious Intermediate or Posterior Uveitis

This study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone for the treatment of non-infectious intermediate or posterior uveitis.

A Study of LX211 in Active Sight Threatening, Non-Infectious Intermediate-, Anterior and Intermediate-, Posterior-, or Pan-Uveitis

The objective of this study is to evaluate the safety and efficacy of LX211 as therapy in subjects with active non-infectious uveitis

A Study of LX211 in Clinically Quiescent Non-Infectious Intermediate, Anterior and Intermediate, Posterior or Pan-Uveitis

The objective of this study is to evaluate the safety and efficacy of LX211 as therapy in subjects with clinically quiescent non-infectious uveitis

PubMed Articles [4600 Associated PubMed Articles listed on BioPortfolio]

Optimising drug therapy for non-infectious uveitis.

Uveitis encompasses a wide variety of sight-threatening diseases characterized by intraocular inflammation. It is often classified as infectious and non-infectious uveitis. Unlike infectious uveitis, ...

Reclassifying Idiopathic Uveitis: Lessons from a Tertiary Uveitis Center.

Idiopathic uveitis is frequently the most common diagnosis in series from uveitis clinics. We sought to determine the percentage of patients initially diagnosed as idiopathic, non-infectious uveitis r...

Disease of the Year: Differential Diagnosis of Uveitic Macular Edema.

Uveitic cystoid macular edema (UME) is an important cause of visual morbidity among patients with both infectious and non-infectious uveitis. UME may be associated in more than 30% cases of active uve...

Aqueous humor analysis identifies higher branched chain amino acid metabolism as a marker for HLA-B27 acute anterior uveitis and disease activity.

HLA-B27 positive acute anterior uveitis has a higher recurrence rate and shows more anterior chamber cell infiltration compared to HLA-B27-negative patients, suggesting distinct etiology of these clin...

Systemic Corticosteroids in Non-infectious Uveitis.

Corticosteroids are essential in the treatment of non-infectious uveitis, rheumatic diseases, autoimmune diseases, allergy, and in the therapy and prevention of transplant rejection. In addition to th...

Medical and Biotech [MESH] Definitions

Inflammation of the pars plana, ciliary body, and adjacent structures.

Human histocompatibility (HLA) surface antigen encoded by the B locus on chromosome 6. It is strongly associated with acute anterior uveitis (UVEITIS, ANTERIOR); ANKYLOSING SPONDYLITIS; and REACTIVE ARTHRITIS.

Inflammation of the choroid as well as the retina and vitreous body. Some form of visual disturbance is usually present. The most important characteristics of posterior uveitis are vitreous opacities, choroiditis, and chorioretinitis.

Encysted cercaria which house the intermediate stages of trematode parasites in tissues of an intermediate host.

Brain inflammation caused by an infectious agent..

More From BioPortfolio on "Myfortic for the Treatment of Non-infectious Intermediate Uveitis"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Clincial Trials
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...

Nutrition
Within medicine, nutrition (the study of food and the effect of its components on the body) has many different roles. Appropriate nutrition can help prevent certain diseases, or treat others. In critically ill patients, artificial feeding by tubes need t...

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