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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

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

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

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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 [4650 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, ...

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...

mTOR-inhibiting pharmacotherapy for the treatment of non-infectious uveitis: a systematic review protocol.

Non-infectious uveitis represents a sub-type of intraocular inflammation often associated with disorders of immune dysregulation. If untreated, the intraocular inflammation may progress to severe visu...

Diagnostic Utility of Quantitative Polymerase Chain Reaction versus Culture in Endophthalmitis and Uveitis.

To compare genetic testing for microbes in infectious endophthalmitis or uveitis to culture.

Superficial and deep retinal foveal avascular zone OCTA findings of non-infectious anterior and posterior uveitis.

To compare the superficial (FAZ-S) and deep foveal avascular zones (FAZ-D) of non-infectious anterior and posterior uveitis to healthy controls, using optical coherence tomography angiography (OCTA).

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..

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