Myfortic for the Treatment of Non-infectious Intermediate Uveitis (MYCUV-IIT02)
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).
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Myfortic (Enteric-coated Mycophenolate Sodium) for the Treatment of Non-infectious Intermediate Uveitis - a Prospective, Controlled, Randomized Multicenter Trial|
- Time from study entry to first relapse [ Time Frame: 6 months ] [ Designated as safety issue: No ]A log-rank test will be used to evaluate differences between the treatment and control group with the null hypothesis of no differences in the survival distributions between the two groups and the alternative hypothesis of different survival distributions. A two-sided log-rank test will be used at a significance level of 0.05.
|Study Start Date:||March 2010|
|Estimated Study Completion Date:||October 2015|
|Estimated Primary Completion Date:||October 2015 (Final data collection date for primary outcome measure)|
|Experimental: Mycophenolate sodium + Decortin||
Myfortic 360 mg BID (during week 1) Myfortic 720 mg BID (from week 2 on) Maintenance dose Decortin 5mg/dDrug: Decortin
Maintenance dose 5 mg/d
|Active Comparator: Decortin||
Maintenance dose 5 mg/d
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01092533
|Charité Universitätsmedizin Berlin, Augenklinik|
|Berlin, Germany, 13353|
|Freiburg, Germany, 79106|
|Universitätsklinikum Heidelberg, Interdisziplinäres Uveitiszentrum|
|Heidelberg, Germany, 69120|
|Augenklinik der Ludwig-Maximilians-Universität München|
|München, Germany, 80336|
|Augenabteilung am St. Franziskus-Hospital Münster|
|Münster, Germany, 48145|
|Principal Investigator:||Christoph Deuter, Dr.||Centre for Ophthalmology, University of Tuebingen|