Status:
COMPLETED
A Study of LX211 in Active Sight Threatening, Non-infectious Intermediate-, Anterior and Intermediate-, Posterior-, or Pan-Uveitis
Lead Sponsor:
Lux Biosciences, Inc.
Conditions:
Uveitis, Posterior
Uveitis, Intermediate
Eligibility:
All Genders
13+ years
Phase:
PHASE3
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
Eligibility Criteria
Inclusion
- 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
- Uveitis of infectious etiology
- Clinically suspected or confirmed central nervous system or ocular lymphoma
- Primary diagnosis of anterior uveitis
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
218 Patients enrolled
Trial Details
Trial ID
NCT00404612
Start Date
January 1 2007
End Date
May 1 2009
Last Update
October 11 2012
Active Locations (41)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
2
Retinal Consultants of Arizona
Phoenix, Arizona, United States, 85014
3
University of Illinois - Chicago
Chicago, Illinois, United States, 60612
4
Midwest Eye Institute
Indianapolis, Indiana, United States, 46280