A Study of LX211 in Clinically Quiescent 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 clinically quiescent non-infectious uveitis

Key facts

Study ID

NCT00404742

Run by

Lux Biosciences, Inc.

People needed

232

Starts

2007-01-01

Expected to finish

2009-05-01

Last updated by the study team

2012-06-22

Who can join

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

You may qualify if…

• 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

You may not qualify if…

• 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

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
• Brian B. Berger, MD, P.A. — 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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