A Study of LX211 in Clinically Quiescent Non-infectious Intermediate, Anterior and Intermediate, Posterior or Pan-Uveitis

• Status: Completed
• Trial end date: 2009-05-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lux Biosciences, Inc.

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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