Uveitis, Posterior Clinical Trial
— LUMINATEOfficial title:
A Double-Masked, Placebo-Controlled, Multi-Center, Parallel-Group, Dose-Ranging Study With an Optional Extension to Assess the Efficacy and Safety of LX211 as Therapy in Subjects With Clinically Quiescent Sight Threatening, Non-infectious Intermediate, Anterior and Intermediate, Posterior or Pan-Uveitis
Verified date | June 2012 |
Source | Lux Biosciences, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
The objective of this study is to evaluate the safety and efficacy of LX211 as therapy in subjects with clinically quiescent non-infectious uveitis
Status | Completed |
Enrollment | 232 |
Est. completion date | May 2009 |
Est. primary completion date | November 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 13 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Austria | Universitätsklinik für Augenheilkunde | Salzburg | |
Austria | Klinik für Augenheilkunde, Dept. of Ophthalmology | Wien | |
Canada | Ivey Eye Institute | London | Ontario |
Canada | McGill University Health Center | Montreal | Quebec |
Canada | University of Ottawa Eye Institute | Ottawa | Ontario |
France | Center Hospitalier Universitaire d' Angers, Service d'Opthalmologie | Angers | |
France | Hôpital Pitié Salpétrière, Service d'Ophtalmologie | Paris | |
Germany | Universitätsklinikum Freiburg | Freiburg | |
Germany | Augenklinik der Universität Heidelberg | Heidelberg | |
Germany | Universitätsklinikum Tübingen | Tübingen | |
India | Vittala International Institute of Ophthalmology | Bangalore | |
India | Consultant, Retina and Vitreous Services, Bhubaneswar L V Prasad Eye Institute | Bhubaneswar | Orissa |
India | Advanced Eye Centre, Postgraduate Institute of Medical Education and Research (PGIMER) | Chandigarh | |
India | Department of Opthalmology, Sankara Nethralaya, Medical Research Foundation, | Chennai | Tamil Nadu |
India | Aravind Eye Hospital, Uvea Clinic | Coimbatore | |
India | L V Prasad Eye Institute | Hyderabaad | Andhra Pradesh |
India | Aravind Eye Hospitals and Postgraduate Institute of Ophthalmology | Madurai | Tamil Nadu |
India | Aditya Jyot Eye Hospital Pvt Ltd | Mumbai | |
India | Dr. R. P. Centre for Ophthalmic Sciences, All India Institute of Medical Sciences | New Delhi | |
United Kingdom | Bristol Eye Hospital and University of Bristol | Bristol | |
United Kingdom | Royal Liverpool University Hospital | Liverpool | |
United Kingdom | Moorfields Eye Hospital | London | |
United States | Texas Retina Associates | Arlington | Texas |
United States | Brian B. Berger, MD, P.A. | Austin | Texas |
United States | Wilmer Eye Institute | Baltimore | Maryland |
United States | University of Alabama at Birmingham | Birmingham | Alabama |
United States | Massachusetts Eye and Ear Infirmary | Boston | Massachusetts |
United States | Massachusetts Eye Research and Surgery Institute | Cambridge | Massachusetts |
United States | University of Illinois - Chicago | Chicago | Illinois |
United States | Texas Retina Associates | Dallas | Texas |
United States | Duke University Eye Center, Erwin Road | Durham | North Carolina |
United States | Associated Retinal Consultants, PC | Grand Rapids | Michigan |
United States | Vitreoretinal Consultants | Houston | Texas |
United States | Midwest Eye Institute | Indianapolis | Indiana |
United States | Tauber Eye Center | Kansas City | Missouri |
United States | New York Eye & Ear Hospital | New York | New York |
United States | UMDNJ-New Jersey Medical School, Ophthalmology Dept. | Newark | New Jersey |
United States | Viginia Eye Consultants | Norfolk | Virginia |
United States | Retinal Consultants of Arizona | Phoenix | Arizona |
United States | Oregon Health Sciences University | Portland | Oregon |
United States | Retina & Uveitis Consultants of Texas | San Antonio | Texas |
Lead Sponsor | Collaborator |
---|---|
Lux Biosciences, Inc. |
United States, Austria, Canada, France, Germany, India, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | recurrence of ocular inflammation | 26 weeks | No | |
Secondary | BCVA | 26 weeks | No | |
Secondary | systemic corticosteroid usage | 26 weeks | No |
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