Uveitis, Intermediate Clinical Trial
Official title:
Myfortic (Enteric-coated Mycophenolate Sodium) for the Treatment of Non-infectious Intermediate Uveitis - a Prospective, Controlled, Randomized Multicenter Trial
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).
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.
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