Status:
COMPLETED
A Study of LX211 in Clinically Quiescent 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 clinically quiescent non-infectious uveitis
Eligibility Criteria
Inclusion
- A documented history of non-infectious intermediate, anterior and intermediate, posterior or panuveitis.
- Minimum prescribed therapy upon enrollment is one or more of the following:
- systemic prednisone or equivalent averaging ≥ 10 mg/day
- at least 2 periocular/intravitreal corticosteroid administrations for control of inflammatory disease within the previous 8 months (but not within 6 weeks of randomization).
- at least one, but not more than 2 immunosuppressive drugs from among the following compounds: cyclosporine, tacrolimus, azathioprine, mycophenolate mofetil, methotrexate
- Subjects with clinically quiescent uveitis in both eyes at enrollment and who have been on a stable treatment regimen for a minimum of 6 weeks
- Best-corrected distance visual acuity in the worst involved eye of 20/400 or better (ETDRS logMAR \<1.34)
- Subjects not planning to undergo elective ocular surgery during the study
Exclusion
- Evidence of active, uncontrolled non-infectious uveitis
- Periocular administration of corticosteroids within the previous 6 weeks.
- Uveitis of infectious etiology
- Uncontrolled glaucoma
- Clinically suspected or confirmed central nervous system or ocular lymphoma
- History or diagnosis of Behçet's disease
- 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 :
232 Patients enrolled
Trial Details
Trial ID
NCT00404742
Start Date
January 1 2007
End Date
May 1 2009
Last Update
June 22 2012
Active Locations (41)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States
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