A Study of LX211 in Active Sight Threatening, Non-infectious Intermediate-, Anterior and Intermediate-, Posterior-, or Pan-Uveitis
NCT ID: NCT00404612
Last Updated: 2012-10-11
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
218 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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Keywords
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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
* Current uveitis therapy must conform to one of the following:
1. Prednisone monotherapy at a dose of ≥ 10 mg/day (or equivalent) for ≥ 2 weeks prior to randomization
2. Have received ≥ 2 injections of corticosteroid (intravitreal or periocular) for control of disease within the past 8 months, but not within 2 weeks of randomization; subjects may also be receiving systemic corticosteroid therapy
3. Receiving monotherapy with azathioprine, mycophenolate mofetil, mycophenolic acid or methotrexate for at least 2 weeks prior to randomization
4. Receiving prednisone in addition to one immunomodulatory agent from among cyclosporine, tacrolimus, azathioprine, mycophenolate mofetil, mycophenolic acid and methotrexate for at least 2 weeks prior to randomization
5. Subjects for whom corticosteroid therapy (systemic or local) is medically inappropriate or who refuse corticosteroid therapy
* Grade of 2+ or higher for vitreous haze at time of enrollment
* Considered by the investigator to require immunomodulatory therapy.
* Not planning to undergo elective ocular surgery during the study
Exclusion Criteria
* Clinically suspected or confirmed central nervous system or ocular lymphoma
* Primary diagnosis of anterior uveitis
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
Midwest Eye Institute
Indianapolis, Indiana, 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
UMDNJ-New Jersey Medical School, Ophthalmology Dept.
Newark, New Jersey, 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
Texas Retina Associates
Arlington, Texas, United States
Retina Research Center
Austin, Texas, United States
Texas Retina Associates
Dallas, Texas, United States
Vitreoretinal Consultants
Houston, 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
Ivey Eye Institute
London, Ontario, Canada
University of Ottawa Eye Institute
Ottawa, Ontario, Canada
McGill University Health Center
Montreal, Quebec, Canada
Center Hospitalier Universitaire d' Angers, Service d'Opthalmologie
Angers, , France
Hôpital Pitié Salpétrière, Service d'Ophtalmologie
Paris, , France
Universitätsklinikum Freiburg
Freiburg im Breisgau, , Germany
Augenklinik der Universität Heidelberg
Heidelberg, , Germany
Universitätsklinikum Tübingen
Tübingen, , Germany
L V Prasad Eye Institute
Hyderabaad, Andhra Pradesh, India
Consultant, Retina and Vitreous Services, Bhubaneswar L V Prasad Eye Institute
Bhubaneswar, Odisha, India
Department of Opthalmology, Sankara Nethralaya, Medical Research Foundation,
Chennai, Tamil Nadu, 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
Dr. R. P. Centre for Ophthalmic Sciences, All India Institute of Medical Sciences
New Delhi, , India
Bristol Eye Hospital and University of Bristol
Bristol, , United Kingdom
Royal Liverpool University Hospital
Liverpool, , United Kingdom
Moorfields Eye Hospital
London, , United Kingdom
Countries
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Related Links
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Related Info
Other Identifiers
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EudraCT No: 2006-006543-31
Identifier Type: -
Identifier Source: secondary_id
LX211-01-UV
Identifier Type: -
Identifier Source: org_study_id