Back to resultsA Study of LX211 in Active Sight Threatening, Non-infectious Intermediate-, Anterior and Intermediate-, Posterior-, or Pan-Uveitis (LUMINATE)
Primary Purpose
Uveitis, Posterior, Uveitis, Intermediate, 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, Posterior focused on measuring uveitis, calcineurin
Eligibility Criteria
Inclusion Criteria:
- Documented history of non-infectious intermediate-, anterior and intermediate-, posterior- or panuveitis uveitis
Current uveitis therapy must conform to one of the following:
- Prednisone monotherapy at a dose of ≥ 10 mg/day (or equivalent) for ≥ 2 weeks prior to randomization
- 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
- Receiving monotherapy with azathioprine, mycophenolate mofetil, mycophenolic acid or methotrexate for at least 2 weeks prior to randomization
- 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
- 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:
- Uveitis of infectious etiology
- Clinically suspected or confirmed central nervous system or ocular lymphoma
- Primary diagnosis of anterior uveitis
Sites / Locations
- University of Alabama at Birmingham
- Retinal Consultants of Arizona
- University of Illinois - Chicago
- Midwest Eye Institute
- Wilmer Eye Institute
- Massachusetts Eye and Ear Infirmary
- Massachusetts Eye Research and Surgery Institute
- Associated Retinal Consultants, PC
- Tauber Eye Center
- UMDNJ-New Jersey Medical School, Ophthalmology Dept.
- New York Eye & Ear Hospital
- Duke University Eye Center, Erwin Road
- Oregon Health Sciences University
- Texas Retina Associates
- Retina Research Center
- Texas Retina Associates
- Vitreoretinal Consultants
- Retina & Uveitis Consultants of Texas
- Viginia Eye Consultants
- Universitätsklinik für Augenheilkunde
- Klinik für Augenheilkunde, Dept. of Ophthalmology
- Ivey Eye Institute
- University of Ottawa Eye Institute
- McGill University Health Center
- Center Hospitalier Universitaire d' Angers, Service d'Opthalmologie
- Hôpital Pitié Salpétrière, Service d'Ophtalmologie
- Universitätsklinikum Freiburg
- Augenklinik der Universität Heidelberg
- Universitätsklinikum Tübingen
- L V Prasad Eye Institute
- Consultant, Retina and Vitreous Services, Bhubaneswar L V Prasad Eye Institute
- Department of Opthalmology, Sankara Nethralaya, Medical Research Foundation,
- 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
- Dr. R. P. Centre for Ophthalmic Sciences, All India Institute of Medical Sciences
- Bristol Eye Hospital and University of Bristol
- Royal Liverpool University Hospital
- Moorfields Eye 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
vitreous haze
Secondary Outcome Measures
BCVA
Full Information
NCT ID
NCT00404612
First Posted
November 27, 2006
Last Updated
October 9, 2012
Sponsor
Lux Biosciences, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00404612
Brief Title
A Study of LX211 in Active Sight Threatening, Non-infectious Intermediate-, Anterior and Intermediate-, Posterior-, or Pan-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 Intermediate-, Anterior and Intermediate-, Posterior-, or Pan-Uveitis
Study Type
Interventional
2. Study Status
Record Verification Date
October 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 uveitis
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uveitis, Posterior, Uveitis, Intermediate, Panuveitis
Keywords
uveitis, calcineurin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
218 (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
vitreous haze
Time Frame
16 and 24 weeks
Secondary Outcome Measure Information:
Title
BCVA
Time Frame
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 intermediate-, anterior and intermediate-, posterior- or panuveitis uveitis
Current uveitis therapy must conform to one of the following:
Prednisone monotherapy at a dose of ≥ 10 mg/day (or equivalent) for ≥ 2 weeks prior to randomization
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
Receiving monotherapy with azathioprine, mycophenolate mofetil, mycophenolic acid or methotrexate for at least 2 weeks prior to randomization
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
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:
Uveitis of infectious etiology
Clinically suspected or confirmed central nervous system or ocular lymphoma
Primary diagnosis of anterior uveitis
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
ZIP/Postal Code
35233
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
Midwest Eye Institute
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46280
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
ZIP/Postal Code
02114
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
UMDNJ-New Jersey Medical School, Ophthalmology Dept.
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
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
Texas Retina Associates
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Facility Name
Retina Research Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Texas Retina Associates
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Vitreoretinal Consultants
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
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
Ivey Eye Institute
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4G5
Country
Canada
Facility Name
University of Ottawa Eye Institute
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
McGill University Health Center
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 1A1
Country
Canada
Facility Name
Center Hospitalier Universitaire d' Angers, Service d'Opthalmologie
City
Angers
Country
France
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
Universitätsklinikum Tübingen
City
Tübingen
Country
Germany
Facility Name
L V Prasad Eye Institute
City
Hyderabaad
State/Province
Andhra Pradesh
Country
India
Facility Name
Consultant, Retina and Vitreous Services, Bhubaneswar L V Prasad Eye Institute
City
Bhubaneswar
State/Province
Orissa
Country
India
Facility Name
Department of Opthalmology, Sankara Nethralaya, Medical Research Foundation,
City
Chennai
State/Province
Tamil Nadu
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
Dr. R. P. Centre for Ophthalmic Sciences, All India Institute of Medical Sciences
City
New Delhi
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
Facility Name
Moorfields Eye Hospital
City
London
Country
United Kingdom
12. IPD Sharing Statement
Links:
URL
http://www.luxbio.com
Description
Related Info
Learn more about this trial
A Study of LX211 in Active Sight Threatening, Non-infectious Intermediate-, Anterior and Intermediate-, Posterior-, or Pan-Uveitis
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