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

Phase 1

• Conditions: non-infectious uveitis; MedDRA version: 14.1Level: PTClassification code 10046851Term: UveitisSystem Organ Class: 10015919 - Eye disorders

• Registration Number: EUCTR2009-009998-10-DE
• Lead Sponsor: Centre for Ophthalmology, University of Tuebingen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12-02
• Last Update Posted: 22 May 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 144

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:
oGrade 2+ or higher for vitreous haze
oGrade 2+ or higher for anterior chamber cells
oPresence of cystoid macular edema in OCT
oPresence 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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified