A Multi-center Study to Assess the Efficacy and Safety of LX211 in Active Non-infectious Anterior Uveitis

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Brief Title

A Multi-center Study to Assess the Efficacy and Safety of LX211 in Active Non-infectious Anterior Uveitis

Official Title

A Double-Masked, Placebo-Controlled, Parallel-Group, Multi-Center, Dose-Ranging Study With an Optional Extension to Assess the Efficacy and Safety of LX211 as Therapy in Subjects With Active Sight Threatening, Non-infectious Anterior Uveitis

Brief Summary

      The objective of this study is to evaluate the safety and efficacy of LX211 as therapy in
      subjects with active non-infectious anterior uveitis
    


Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

anterior chamber cells

Secondary Outcome

 BCVA

Condition

Uveitis, Anterior

Intervention

Placebo

Study Arms / Comparison Groups

 Placebo
Description:  

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

Drug

Estimated Enrollment

108

Start Date

January 2007

Completion Date

May 2009

Primary Completion Date

November 2008

Eligibility Criteria

        Inclusion Criteria:

          -  Documented history of non-infectious anterior, anterior and intermediate- or
             panuveitis

          -  Currently uncontrolled uveitis for a minimum of 2 weeks despite use of oral and/or
             topical corticosteroid,or subjects who are intolerant of local corticosteroid therapy
             due to the development of an ocular hypertensive response or subjects for whom oral
             corticosteroid is contraindicated.

          -  Grade of 2+ or higher for anterior chamber cells at time of enrollment

          -  Considered by the investigator to require corticosteroid-sparing therapy.

          -  Subjects not planning to undergo elective ocular surgery during the study

        Exclusion Criteria:

          -  Uveitis of infectious etiology

          -  Presence of an ocular toxoplasmosis scar

          -  An immune suppression regimen that includes an alkylating agent within the previous 90
             days
      

Gender

All

Ages

13 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Eddy Anglade, M.D., , 

Location Countries

Austria

Location Countries

Austria

Administrative Informations


NCT ID

NCT00404885

Organization ID

LX211-03-UV

Secondary IDs

EudraCT No: 2006-006545-13

Responsible Party

Sponsor

Study Sponsor

Lux Biosciences, Inc.


Study Sponsor

Eddy Anglade, M.D., Study Chair, Chief Medical Officer


Verification Date

June 2012