Back to resultsA Multi-center Study to Assess the Efficacy and Safety of LX211 in Active Non-infectious Anterior Uveitis (LUMINATE)
Primary Purpose
Uveitis, Anterior, Panuveitis
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Placebo
LX211
LX211
LX211
Sponsored by
About this trial
This is an interventional treatment trial for Uveitis, Anterior focused on measuring uveitis, calcineurin, inflammation
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
Sites / Locations
- University of Alabama at Birmingham
- Retinal Consultants of Arizona
- University of Illinois - Chicago
- Wilmer Eye Institute
- Massachusetts Eye and Ear Infirmary
- Massachusetts Eye Research and Surgery Institute
- Associated Retinal Consultants, PC
- Tauber Eye Center
- New York Eye & Ear Hospital
- Duke University Eye Center, Erwin Road
- Oregon Health Sciences University
- Brian B. Berger, MD, P.A.
- Retina & Uveitis Consultants of Texas
- Viginia Eye Consultants
- Universitätsklinik für Augenheilkunde
- Klinik für Augenheilkunde, Dept. of Ophthalmology
- McGill University Health Center
- Hôpital Pitié Salpétrière, Service d'Ophtalmologie
- Universitätsklinikum Freiburg
- Augenklinik der Universität Heidelberg
- St. Franziskus-Hospital
- Universitätsklinikum Tübingen
- L V Prasad Eye Institute
- Aravind Eye Hospitals and Postgraduate Institute of Ophthalmology
- Vittala International Institute of Ophthalmology
- Advanced Eye Centre, Postgraduate Institute of Medical Education and Research (PGIMER)
- Aravind Eye Hospital, Uvea Clinic
- Aditya Jyot Eye Hospital Pvt Ltd
- Bristol Eye Hospital and University of Bristol
- Royal Liverpool University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
Placebo
LX211, 0.2 mg/kg
LX211, 0.4 mg/kg
LX211, 0.6 mg/kg
Arm Description
Outcomes
Primary Outcome Measures
anterior chamber cells
Secondary Outcome Measures
BCVA
macular thickness
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00404885
Brief Title
A Multi-center Study to Assess the Efficacy and Safety of LX211 in Active Non-infectious Anterior Uveitis
Acronym
LUMINATE
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
May 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lux Biosciences, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uveitis, Anterior, Panuveitis
Keywords
uveitis, calcineurin, inflammation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
108 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
LX211, 0.2 mg/kg
Arm Type
Active Comparator
Arm Title
LX211, 0.4 mg/kg
Arm Type
Active Comparator
Arm Title
LX211, 0.6 mg/kg
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
PO BID
Intervention Type
Drug
Intervention Name(s)
LX211
Intervention Description
0.2 mg/kg, twice a day (BID)
Intervention Type
Drug
Intervention Name(s)
LX211
Intervention Description
0.4 mg/kg, twice a day (BID)
Intervention Type
Drug
Intervention Name(s)
LX211
Intervention Description
0.6 mg/kg, twice a day (BID)
Primary Outcome Measure Information:
Title
anterior chamber cells
Time Frame
16 and 24 weeks
Secondary Outcome Measure Information:
Title
BCVA
Time Frame
24 weeks
Title
macular thickness
Time Frame
16 and 24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eddy Anglade, M.D.
Organizational Affiliation
Chief Medical Officer
Official's Role
Study Chair
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
Retinal Consultants of Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85014
Country
United States
Facility Name
University of Illinois - Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Wilmer Eye Institute
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Massachusetts Eye and Ear Infirmary
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
Massachusetts Eye Research and Surgery Institute
City
Cambridge
State/Province
Massachusetts
ZIP/Postal Code
02142
Country
United States
Facility Name
Associated Retinal Consultants, PC
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49546
Country
United States
Facility Name
Tauber Eye Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
New York Eye & Ear Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Duke University Eye Center, Erwin Road
City
Durham
State/Province
North Carolina
Country
United States
Facility Name
Oregon Health Sciences University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97201
Country
United States
Facility Name
Brian B. Berger, MD, P.A.
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Retina & Uveitis Consultants of Texas
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Facility Name
Viginia Eye Consultants
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Universitätsklinik für Augenheilkunde
City
Salzburg
Country
Austria
Facility Name
Klinik für Augenheilkunde, Dept. of Ophthalmology
City
Wien
Country
Austria
Facility Name
McGill University Health Center
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 1A1
Country
Canada
Facility Name
Hôpital Pitié Salpétrière, Service d'Ophtalmologie
City
Paris
Country
France
Facility Name
Universitätsklinikum Freiburg
City
Freiburg
Country
Germany
Facility Name
Augenklinik der Universität Heidelberg
City
Heidelberg
Country
Germany
Facility Name
St. Franziskus-Hospital
City
Münster
Country
Germany
Facility Name
Universitätsklinikum Tübingen
City
Tübingen
Country
Germany
Facility Name
L V Prasad Eye Institute
City
Hyderabaad
State/Province
Andhra Pradesh
Country
India
Facility Name
Aravind Eye Hospitals and Postgraduate Institute of Ophthalmology
City
Madurai
State/Province
Tamil Nadu
Country
India
Facility Name
Vittala International Institute of Ophthalmology
City
Bangalore
Country
India
Facility Name
Advanced Eye Centre, Postgraduate Institute of Medical Education and Research (PGIMER)
City
Chandigarh
Country
India
Facility Name
Aravind Eye Hospital, Uvea Clinic
City
Coimbatore
Country
India
Facility Name
Aditya Jyot Eye Hospital Pvt Ltd
City
Mumbai
Country
India
Facility Name
Bristol Eye Hospital and University of Bristol
City
Bristol
Country
United Kingdom
Facility Name
Royal Liverpool University Hospital
City
Liverpool
Country
United Kingdom
12. IPD Sharing Statement
Links:
URL
http://www.luxbio.com
Description
Related Info
Learn more about this trial
A Multi-center Study to Assess the Efficacy and Safety of LX211 in Active Non-infectious Anterior Uveitis
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