A Multi-center Study to Assess the Efficacy and Safety of LX211 in Active Non-infectious Anterior Uveitis
- Registration Number
- NCT00404885
- Lead Sponsor
- Lux Biosciences, Inc.
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 108
- 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
- Uveitis of infectious etiology
- Presence of an ocular toxoplasmosis scar
- An immune suppression regimen that includes an alkylating agent within the previous 90 days
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - LX211, 0.2 mg/kg LX211 - LX211, 0.4 mg/kg LX211 - LX211, 0.6 mg/kg LX211 -
- Primary Outcome Measures
Name Time Method anterior chamber cells 16 and 24 weeks
- Secondary Outcome Measures
Name Time Method BCVA 24 weeks macular thickness 16 and 24 weeks
Trial Locations
- Locations (30)
Universitätsklinikum Freiburg
🇩🇪Freiburg, Germany
Advanced Eye Centre, Postgraduate Institute of Medical Education and Research (PGIMER)
🇮🇳Chandigarh, India
University of Illinois - Chicago
🇺🇸Chicago, Illinois, United States
Aravind Eye Hospitals and Postgraduate Institute of Ophthalmology
🇮🇳Madurai, Tamil Nadu, 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
Vittala International Institute of Ophthalmology
🇮🇳Bangalore, India
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Retinal Consultants of Arizona
🇺🇸Phoenix, Arizona, 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
Tauber Eye Center
🇺🇸Kansas City, Missouri, United States
Associated Retinal Consultants, PC
🇺🇸Grand Rapids, Michigan, United States
New York Eye & Ear Hospital
🇺🇸New York, New York, United States
Retina & Uveitis Consultants of Texas
🇺🇸San Antonio, Texas, United States
Oregon Health Sciences University
🇺🇸Portland, Oregon, United States
Brian B. Berger, MD, P.A.
🇺🇸Austin, Texas, United States
Duke University Eye Center, Erwin Road
🇺🇸Durham, North Carolina, United States
Klinik für Augenheilkunde, Dept. of Ophthalmology
🇦🇹Wien, Austria
Universitätsklinik für Augenheilkunde
🇦🇹Salzburg, Austria
Viginia Eye Consultants
🇺🇸Norfolk, Virginia, United States
McGill University Health Center
🇨🇦Montreal, Quebec, Canada
Hôpital Pitié Salpétrière, Service d'Ophtalmologie
🇫🇷Paris, France
St. Franziskus-Hospital
🇩🇪Münster, Germany
Universitätsklinikum Tübingen
🇩🇪Tübingen, Germany
Augenklinik der Universität Heidelberg
🇩🇪Heidelberg, Germany
L V Prasad Eye Institute
🇮🇳Hyderabaad, Andhra Pradesh, India
Royal Liverpool University Hospital
🇬🇧Liverpool, United Kingdom