Myfortic (enteric-coated mycophenolate sodium) for the treatment of non-infectous intermediate uveitis – a prospective, controlled randomized multicenter trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-009998-10-DE

Enrollment

144

Registered

2009-12-02

Start date

2010-02-24

Completion date

Unknown

Last updated

2017-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

non-infectious uveitis MedDRA version: 14.1 Level: PT Classification code 10046851 Term: Uveitis System Organ Class: 10015919 - Eye disorders

Interventions

Trade Name: Myfortic Filmtabletten Pharmaceutical Form: Gastro-resistant tablet CAS Number: 37415-62-6 Other descriptive name: MYCOPHENOLATE SODIUM Concentration unit: mg milligram(s) Concentration ty

Eligibility

Sex/Gender

All

Inclusion 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 timeoint of enrolment according to at least one of the following criteria: o Grade 2+ or higher for vitreous haze o Grade 2+ or higher for anterior chamber cells o Presence of cystoid macular edema in OCT o Presence of retinal vessel leakage in FA Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • Uveitis of infectious etiology • Clinically suspected or confirmed central nervous system or ocular lymphoma • Primary diagnosis of anterior or posterior uveitis

Design outcomes

Primary

Measure	Time frame
Main Objective: The objective of this clinical trial to evaluate the efficacy, safety and tolerability of enteric-coated mycophenolate sodium in combination with low-dose corticosteroids compared to a monotherapy with low-dose corticosteroids in subjects with non-infectious intermediate uveitis. ;Secondary Objective: To test whether a Myfortic based therapy provides a superior behaviour compared to a steroid regimen in terms of: • Time to relapse before and after switch from control arm to treatment arm • Dose of steroids at the timepoint of relapse before and after switch from control arm to treatment arm • Change from baseline in Best Corrected Visual Acuity (BCVA) using the Early Treatment Diabetic Retinopathy Study (ETDRS) method • Change from baseline in foveal thickness, measured by Optical Coherence Tomography (OCT) • Change from baseline in retinal vessel leakage, measured by Fluorescein Angiography (FA) • Number and severity of adverse events • Ratio of patients with need of dose reduction for mycophenolate sodium due to side effects ;Primary end point(s): To evaluate whether a Myfortic based regimen will be able to reduce the probability of a relapse compared to steroid therapy alone. The primary endpoint of the study is defined as the time from study entry to the first relapse. Definition of relapse: • Deterioration of BCVA = 3 lines compared to best BCVA from baseline. • At least 2-step increase of vitreous haze compared to lowest grade of vitreous haze from baseline or increase from 3+ to 4+. • At least 2-step increase of anterior chamber cells compared to lowest grade of anterior chamber cells from baseline or increase from 3+ to 4+. • New onset or worsening of pre-existing cystoid macular edema, proven by Optical Coherence Tomography (OCT) • New onset or worsening of retinal vasculitis (sheating and/or leakage of retinal vessels), proven by fluorescein angiography (FA)	—

Measure

Time frame

Main Objective: The objective of this clinical trial to evaluate the efficacy, safety and tolerability of enteric-coated mycophenolate sodium in combination with low-dose corticosteroids compared to a monotherapy with low-dose corticosteroids in subjects with non-infectious intermediate uveitis. ;Secondary Objective: To test whether a Myfortic based therapy provides a superior behaviour compared to a steroid regimen in terms of: • Time to relapse before and after switch from control arm to treatment arm • Dose of steroids at the timepoint of relapse before and after switch from control arm to treatment arm • Change from baseline in Best Corrected Visual Acuity (BCVA) using the Early Treatment Diabetic Retinopathy Study (ETDRS) method • Change from baseline in foveal thickness, measured by Optical Coherence Tomography (OCT) • Change from baseline in retinal vessel leakage, measured by Fluorescein Angiography (FA) • Number and severity of adverse events • Ratio of patients with need of dose reduction for mycophenolate sodium due to side effects ;Primary end point(s): To evaluate whether a Myfortic based regimen will be able to reduce the probability of a relapse compared to steroid therapy alone. The primary endpoint of the study is defined as the time from study entry to the first relapse. Definition of relapse: • Deterioration of BCVA = 3 lines compared to best BCVA from baseline. • At least 2-step increase of vitreous haze compared to lowest grade of vitreous haze from baseline or increase from 3+ to 4+. • At least 2-step increase of anterior chamber cells compared to lowest grade of anterior chamber cells from baseline or increase from 3+ to 4+. • New onset or worsening of pre-existing cystoid macular edema, proven by Optical Coherence Tomography (OCT) • New onset or worsening of retinal vasculitis (sheating and/or leakage of retinal vessels), proven by fluorescein angiography (FA)

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Countries

Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026