A Study of LX211 in Clinically Quiescent Non-Infectious Intermediate, Anterior and Intermediate, Posterior or Pan-Uveitis - Tabular View

Tracking Information
First Received Date ^ICMJE	November 27, 2006
Last Updated Date	July 8, 2008
Start Date ^ICMJE	January 2007
Primary Completion Date	May 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: April 23, 2007)	recurrence of ocular inflammation
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00404742 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: April 23, 2007)	vitreous haze anterior chamber cells BCVA systemic corticosteroid usage
Original Secondary Outcome Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	A Study of LX211 in Clinically Quiescent Non-Infectious Intermediate, Anterior and Intermediate, Posterior or Pan-Uveitis
Official Title ^ICMJE	A Double-Masked, Placebo-Controlled, Multi-Center, Parallel-Group, Dose-Ranging Study With an Optional Extension to Assess the Efficacy and Safety of LX211 as Therapy in Subjects With Clinically Quiescent Sight Threatening, Non-Infectious Intermediate, Anterior and Intermediate, Posterior or Pan-Uveitis
Brief Summary	The objective of this study is to evaluate the safety and efficacy of LX211 as therapy in subjects with clinically quiescent non-infectious uveitis
Detailed Description
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Uveitis, Posterior Uveitis, Intermediate Panuveitis
Intervention ^ICMJE	Drug: LX211
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE
Completion Date
Primary Completion Date	May 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: A documented history of non-infectious intermediate, anterior and intermediate, posterior or panuveitis. Minimum prescribed therapy upon enrollment is one or more of the following: systemic prednisone or equivalent averaging ≥ 10 mg/day at least 2 periocular/intravitreal corticosteroid administrations for control of inflammatory disease within the previous 8 months (but not within 6 weeks of randomization). at least one, but not more than 2 immunosuppressive drugs from among the following compounds: cyclosporine, tacrolimus, azathioprine, mycophenolate mofetil, methotrexate Subjects with clinically quiescent uveitis in both eyes at enrollment and who have been on a stable treatment regimen for a minimum of 6 weeks Best-corrected distance visual acuity in the worst involved eye of 20/400 or better (ETDRS logMAR <1.34) Subjects not planning to undergo elective ocular surgery during the study Exclusion Criteria: Evidence of active, uncontrolled non-infectious uveitis Periocular administration of corticosteroids within the previous 6 weeks. Uveitis of infectious etiology Uncontrolled glaucoma Clinically suspected or confirmed central nervous system or ocular lymphoma History or diagnosis of Behçet's disease Primary diagnosis of anterior uveitis
Gender	Both
Ages	13 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Austria, Canada, France, Germany, India, United Kingdom

Administrative Information
NCT ID ^ICMJE	NCT00404742
Responsible Party
Study ID Numbers ^ICMJE	LX211-02-UV, EudraCT No: 2006-006544-66
Study Sponsor ^ICMJE	Lux Biosciences, Inc.
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Lux Biosciences, Inc.
Verification Date	July 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP