A Study of LX211 in Active Sight Threatening, 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 active non-infectious uveitis

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

Details

• Lead Sponsor: Lux Biosciences, Inc.

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:

1. Prednisone monotherapy at a dose of ≥ 10 mg/day (or equivalent) for ≥ 2 weeks prior to randomization

2. 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

3. Receiving monotherapy with azathioprine, mycophenolate mofetil, mycophenolic acid or methotrexate for at least 2 weeks prior to randomization

4. 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

5. 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