A Study of LX211 in Clinically Quiescent Non-infectious Intermediate, Anterior and Intermediate, … (NCT00404742) | Clinical Trial Compass
CompletedPhase 3
A Study of LX211 in Clinically Quiescent Non-infectious Intermediate, Anterior and Intermediate, Posterior or Pan-Uveitis
United States232 participantsStarted 2007-01
Plain-language 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
Who can participate
Age range13 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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