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

Lux Biosciences, Inc.40 sites in 7 countries218 target enrollmentJanuary 2007

InterventionsPlacebo LX211

Overview

The objective of this study is to evaluate the safety and efficacy of LX211 as therapy in subjects with active non-infectious uveitis

Registry

clinicaltrials.gov

Start Date

January 2007

End Date

May 2009

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Sponsor

Responsible Party

Sponsor

•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