A Multi-center, Double Masked, Parallel Group, Placebo-Controlled Study to Assess the Efficacy and Safety of Voclosporin as Therapy in Subjects with Active Noninfectious Intermediate, Posterior or Pan-uveitis. - ND

• Conditions: Active noninfectious uveitis involving the intermediate and/or the posterior segment in at least one eye as evidenced by a vitreous haze grade of at least 2+ at Baseline; MedDRA version: 9.1Level: LLTClassification code 10019180; MedDRA version: 9.1Level: LLTClassification code 10023418; MedDRA version: 9.1Level: LLTClassification code 10019211; MedDRA version: 9.1Level: LLTClassification code 10012735

• Registration Number: EUCTR2010-022128-63-IT
• Lead Sponsor: X BIOSCIENCES, INC.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12-14
• Last Update Posted: 7 January 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

1 - Active noninfectious uveitis involving the intermediate and/or posterior segmant in at least one eye 2 - A minimum ability to count fingers at a distance of 30 cm in both eyes. 3 - At least 18 years of age. 4 - Considered by the Investigator to require systemic immunosuppressive therapy. 5 - Able to give written informed consent. (if the subject does not have the legal capacity to consent, written informed consent may be provided by a legal representative on behalf of the subject)
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) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1 - Uveitis limited to only the anterior segment in the study eye. 2 - Confirmed or suspected infection uveitis in either eyes, including, but not limited to infectious uveitis due to tubercolosis, cytomegalovirus, Lyme disease, toxoplasmosis. 3 - Presence of an ocular toxoplasmosis scar or suspected active infection in either eye. 4 - Active infection in either eye 5 - Serpiginous choroidopathy in either eye 6 - Intraocular pressure of > 21 mmHg in either eye

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary obiective of this study is to assess the safety and efficacy of voclosporin as therapy in subjects with active noninfectious uveitis involving the intermediate and/or posterior ocular segmants.;Secondary Objective: The secondary objective of this study is to assess the relationship of voclosporin exposure to efficacy and safety parameters.;Primary end point(s): Mean change from baseline in graded vitreous haze in the study eye at 12 weeks of therapy or at time of treatment failure, if earlier.