A Multi-center Study to Assess the Efficacy and Safety of LX211 in Active Non-infectious Anterior Uveitis
NCT ID: NCT00404885
Last Updated: 2012-06-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
108 participants
INTERVENTIONAL
2007-01-31
2009-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Placebo
PO BID
LX211, 0.2 mg/kg
LX211
0.2 mg/kg, twice a day (BID)
LX211, 0.4 mg/kg
LX211
0.4 mg/kg, twice a day (BID)
LX211, 0.6 mg/kg
LX211
0.6 mg/kg, twice a day (BID)
Interventions
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Placebo
PO BID
LX211
0.2 mg/kg, twice a day (BID)
LX211
0.4 mg/kg, twice a day (BID)
LX211
0.6 mg/kg, twice a day (BID)
Eligibility Criteria
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Inclusion Criteria
* 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
* Presence of an ocular toxoplasmosis scar
* An immune suppression regimen that includes an alkylating agent within the previous 90 days
13 Years
ALL
No
Sponsors
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Lux Biosciences, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Eddy Anglade, M.D.
Role: STUDY_CHAIR
Chief Medical Officer
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Retinal Consultants of Arizona
Phoenix, Arizona, United States
University of Illinois - Chicago
Chicago, Illinois, United States
Wilmer Eye Institute
Baltimore, Maryland, United States
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, United States
Massachusetts Eye Research and Surgery Institute
Cambridge, Massachusetts, United States
Associated Retinal Consultants, PC
Grand Rapids, Michigan, United States
Tauber Eye Center
Kansas City, Missouri, United States
New York Eye & Ear Hospital
New York, New York, United States
Duke University Eye Center, Erwin Road
Durham, North Carolina, United States
Oregon Health Sciences University
Portland, Oregon, United States
Brian B. Berger, MD, P.A.
Austin, Texas, United States
Retina & Uveitis Consultants of Texas
San Antonio, Texas, United States
Viginia Eye Consultants
Norfolk, Virginia, United States
Universitätsklinik für Augenheilkunde
Salzburg, , Austria
Klinik für Augenheilkunde, Dept. of Ophthalmology
Vienna, , Austria
McGill University Health Center
Montreal, Quebec, Canada
Hôpital Pitié Salpétrière, Service d'Ophtalmologie
Paris, , France
Universitätsklinikum Freiburg
Freiburg im Breisgau, , Germany
Augenklinik der Universität Heidelberg
Heidelberg, , Germany
St. Franziskus-Hospital
Münster, , Germany
Universitätsklinikum Tübingen
Tübingen, , Germany
L V Prasad Eye Institute
Hyderabaad, Andhra Pradesh, India
Aravind Eye Hospitals and Postgraduate Institute of Ophthalmology
Madurai, Tamil Nadu, India
Vittala International Institute of Ophthalmology
Bangalore, , India
Advanced Eye Centre, Postgraduate Institute of Medical Education and Research (PGIMER)
Chandigarh, , India
Aravind Eye Hospital, Uvea Clinic
Coimbatore, , India
Aditya Jyot Eye Hospital Pvt Ltd
Mumbai, , India
Bristol Eye Hospital and University of Bristol
Bristol, , United Kingdom
Royal Liverpool University Hospital
Liverpool, , United Kingdom
Countries
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Related Links
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Related Info
Other Identifiers
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EudraCT No: 2006-006545-13
Identifier Type: -
Identifier Source: secondary_id
LX211-03-UV
Identifier Type: -
Identifier Source: org_study_id
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