A Study of LX211 in Active Sight Threatening, Non-infectious Intermediate-, Anterior and Intermediate-, Posterior-, or Pan-Uveitis

Completed · Phase 3 · Has a placebo group

Conditions studied: Uveitis, Posterior, Uveitis, Intermediate, Panuveitis

In brief

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

Key facts

Study ID

NCT00404612

Run by

Lux Biosciences, Inc.

People needed

218

Starts

2007-01-01

Expected to finish

2009-05-01

Last updated by the study team

2012-10-11

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Uveitis of infectious etiology
• Clinically suspected or confirmed central nervous system or ocular lymphoma
• Primary diagnosis of anterior uveitis

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Retinal Consultants of Arizona — Phoenix, Arizona, United States
• University of Illinois - Chicago — Chicago, Illinois, United States
• Midwest Eye Institute — Indianapolis, Indiana, United States
• Wilmer Eye Institute — Baltimore, Maryland, United States
• Massachusetts Eye and Ear Infirmary — Boston, Massachusetts, United States
• Massachusetts Eye Research and Surgery Institute — Cambridge, Massachusetts, United States
• Associated Retinal Consultants, PC — Grand Rapids, Michigan, United States
• Tauber Eye Center — Kansas City, Missouri, United States
• UMDNJ-New Jersey Medical School, Ophthalmology Dept. — Newark, New Jersey, United States
• New York Eye & Ear Hospital — New York, New York, United States
• Duke University Eye Center, Erwin Road — Durham, North Carolina, United States
• Oregon Health Sciences University — Portland, Oregon, United States
• Texas Retina Associates — Arlington, Texas, United States
• Retina Research Center — Austin, Texas, United States
• Texas Retina Associates — Dallas, Texas, United States
• Vitreoretinal Consultants — Houston, Texas, United States
• Retina & Uveitis Consultants of Texas — San Antonio, Texas, United States
• Viginia Eye Consultants — Norfolk, Virginia, United States
• Universitätsklinik für Augenheilkunde — Salzburg, Austria
• Klinik für Augenheilkunde, Dept. of Ophthalmology — Vienna, Austria
• Ivey Eye Institute — London, Ontario, Canada
• University of Ottawa Eye Institute — Ottawa, Ontario, Canada
• McGill University Health Center — Montreal, Quebec, Canada
• Center Hospitalier Universitaire d' Angers, Service d'Opthalmologie — Angers, France

Full record on ClinicalTrials.gov

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