A Multi-center Study to Assess the Efficacy and Safety of LX211 in Active Non-infectious Anterior Uveitis
LUMINATE
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
2 other identifiers
interventional
108
7 countries
30
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jan 2007
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 27, 2006
CompletedFirst Posted
Study publicly available on registry
November 29, 2006
CompletedStudy Start
First participant enrolled
January 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2009
CompletedJune 22, 2012
June 1, 2012
1.8 years
November 27, 2006
June 21, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
anterior chamber cells
16 and 24 weeks
Secondary Outcomes (2)
BCVA
24 weeks
macular thickness
16 and 24 weeks
Study Arms (4)
Placebo
PLACEBO COMPARATORLX211, 0.2 mg/kg
ACTIVE COMPARATORLX211, 0.4 mg/kg
ACTIVE COMPARATORLX211, 0.6 mg/kg
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Uveitis of infectious etiology
- Presence of an ocular toxoplasmosis scar
- An immune suppression regimen that includes an alkylating agent within the previous 90 days
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (30)
University of Alabama at Birmingham
Birmingham, Alabama, United States
Retinal Consultants of Arizona
Phoenix, Arizona, 85014, United States
University of Illinois - Chicago
Chicago, Illinois, 60612, United States
Wilmer Eye Institute
Baltimore, Maryland, 21287, United States
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, United States
Massachusetts Eye Research and Surgery Institute
Cambridge, Massachusetts, 02142, United States
Associated Retinal Consultants, PC
Grand Rapids, Michigan, 49546, United States
Tauber Eye Center
Kansas City, Missouri, 64111, United States
New York Eye & Ear Hospital
New York, New York, 10003, United States
Duke University Eye Center, Erwin Road
Durham, North Carolina, United States
Oregon Health Sciences University
Portland, Oregon, 97201, United States
Brian B. Berger, MD, P.A.
Austin, Texas, 78705, United States
Retina & Uveitis Consultants of Texas
San Antonio, Texas, 78240, United States
Viginia Eye Consultants
Norfolk, Virginia, 23502, United States
Universitätsklinik für Augenheilkunde
Salzburg, Austria
Klinik für Augenheilkunde, Dept. of Ophthalmology
Vienna, Austria
McGill University Health Center
Montreal, Quebec, H3A 1A1, 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
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Eddy Anglade, M.D.
Chief Medical Officer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 27, 2006
First Posted
November 29, 2006
Study Start
January 1, 2007
Primary Completion
November 1, 2008
Study Completion
May 1, 2009
Last Updated
June 22, 2012
Record last verified: 2012-06