myfortic for the treatment of non-infectious intermediate uveitis

Conditions: Uveitis, Intermediate

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).

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.

Eligibility criteria:
inclusion criteria: * subjects with a documented at least 6 months history of unilateral or bilateral intermediate uveitis either idiopathic or due to non-infectious systemic disease (e.g. sarcoidosis, multiple sclerosis) * uveitis has to be considered to be active at the timepoint of enrolment according to at least one of the following criteria: * grade 2+ or higher for vitreous haze * grade 2+ or higher for anterior chamber cells * presence of cystoid macular edema in oct * presence of retinal vessel leakage in fa * considered by the investigator to require systemic treatment. * at least 18 years of age * not planning to undergo elective ocular surgery during the study * capable of understanding the purposes and risks of the study, able to give informed consent and to comply with the study requirements * subjects of both gender with reproductive potential who are sexually active agree to use contraception throughout the course of the study and for at least 3 months after completion of their study participation. * women of childbearing potential have to use a highly effective method of birth control defined as one which results in a low failure rate (i.e. less than 1% per year) when used consistently and correctly, such as implants, injectables, combined oral contraceptives, hormonal iuds combined with barrier methods (e.g. condom, diaphragm or spermicide), sexual abstinence or vasectomised partner. * women of childbearing age must have a negative urine pregnancy test (upt) within 48 hours prior to starting study drug and must not be lactating. female subjects of non-childbearing potential must meet at least one of the following criteria: 1. postmenopausal females, defined as: c. females over the age of 60 years. d. females who are 45 to 60 years of age must be amenorrheic for at least 2 years. 2. females who had a hysterectomy and/or bilateral oophorectomy. exclusion criteria: * uveitis of infectious etiology * signs of tuberculosis in chest x-ray during the past 12 months before study entry * clinically suspected or confirmed central nervous system or ocular lymphoma * primary diagnosis of anterior or posterior uveitis * uncontrolled glaucoma or known steroid response * subjects who received treatment with a systemic immunosuppressive drug, a monoclonal antibody or any other biologic therapy within 90 days prior study entry * treatment with mycophenolate mofetil or mycophenolate sodium in the past * treatment with a periocular steroid injection within 6 weeks prior to study entry * presence of absolute contraindications for decortin h and/or myfortic as mentioned in the product informations (appendix 1 and 2) * presence of relative contraindications for decortin h and/or myfortic as mentioned in the product information (appendix 1 and 2) if the disorder leading to the relative contraindication can not sufficiently managed by concomitant medication. * recipients of a solid organ transplant * subjects with lens opacities or obscured ocular media upon enrolment making unable evaluation of the posterior eye segment * subjects with a history of herpes zoster or varicella infection within 3 months before enrollment * active, extraocular infection requiring the prolonged or chronic use of antimicrobial agents or the history/presence of active hepatitis a, b or c * seropositivity for human immunodeficiency virus (hiv) * alanine transaminase (alt), aspartate transaminase (ast), or gamma-glutamyl transferase (ggt) ≥ 2x upper limit of normal (uln) * severe anemia (hemoglobin \< 8 g/dl), leukopenia (white blood cell count \[wbc\] \< 2500 mm3), thrombocytopenia (platelet count \< 80,000 mm3) * current malignancy or a history of malignancy within the previous 5 years * pregnant or lactating women * known allergy for fluorescein natrium * currently participating in another clinical trial with an investigational agent in the 30 days prior to study participation and/or has not recovered from any reversible effects or side effects of prior investigational agent * subjects with non-ocular, medically significant co-morbid conditions that impair normal activities, require systemic corticosteroids or immunosuppressives, or any medical condition that would likely have an impact on the participant´s ability to comply with the study visit schedule * any current or history of substance abuse, psychiatric disorder or a condition that, in the opinion of the investigator, may invalidate communication