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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT No: 2006-006544-66 |
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The objective of this study is to evaluate the safety and efficacy of LX211 as therapy in subjects with clinically quiescent non-infectious uveitis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| LX211, 0.2 mg/kg | Active Comparator |
| |
| LX211, 0.4 mg/kg | Active Comparator |
| |
| LX211, 0.6 mg/kg | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | PO BID |
| |
| LX211 |
| Measure | Description | Time Frame |
|---|---|---|
| recurrence of ocular inflammation | 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| BCVA | 26 weeks | |
| systemic corticosteroid usage | 26 weeks |
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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:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Eddy Anglade, M.D. | Chief Medical Officer | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | United States | |||
| Retinal Consultants of Arizona |
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| Label | URL |
|---|---|
| Related Info | View source |
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| Drug |
0.2 mg/kg, twice a day (BID) |
|
| LX211 | Drug | 0.4 mg/kg, twice a day (BID) |
|
| LX211 | Drug | 0.6 mg/kg, twice a day (BID) |
|
| Phoenix |
| Arizona |
| 85014 |
| United States |
| University of Illinois - Chicago | Chicago | Illinois | 60612 | United States |
| Midwest Eye Institute | Indianapolis | Indiana | 46280 | 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 | 02142 | United States |
| Associated Retinal Consultants, PC | Grand Rapids | Michigan | 49546 | United States |
| Tauber Eye Center | Kansas City | Missouri | 64111 | United States |
| UMDNJ-New Jersey Medical School, Ophthalmology Dept. | Newark | New Jersey | 07103 | United States |
| New York Eye & Ear Hospital | New York | New York | 10003 | United States |
| Duke University Eye Center, Erwin Road | Durham | North Carolina | United States |
| Oregon Health Sciences University | Portland | Oregon | 97201 | United States |
| Texas Retina Associates | Arlington | Texas | 76012 | United States |
| Brian B. Berger, MD, P.A. | Austin | Texas | 78705 | United States |
| Texas Retina Associates | Dallas | Texas | 75231 | United States |
| Vitreoretinal Consultants | Houston | Texas | 77030 | United States |
| Retina & Uveitis Consultants of Texas | San Antonio | Texas | 78240 | United States |
| Viginia Eye Consultants | Norfolk | Virginia | 23502 | United States |
| Universitätsklinik für Augenheilkunde | Salzburg | Austria |
| Klinik für Augenheilkunde, Dept. of Ophthalmology | Vienna | Austria |
| Ivey Eye Institute | London | Ontario | N6A 4G5 | Canada |
| University of Ottawa Eye Institute | Ottawa | Ontario | K1H 8L6 | Canada |
| McGill University Health Center | Montreal | Quebec | H3A 1A1 | Canada |
| Center Hospitalier Universitaire d' Angers, Service d'Opthalmologie | Angers | France |
| Hôpital Pitié Salpétrière, Service d'Ophtalmologie | Paris | France |
| Universitätsklinikum Freiburg | Freiburg im Breisgau | Germany |
| Augenklinik der Universität Heidelberg | Heidelberg | Germany |
| Universitätsklinikum Tübingen | Tübingen | Germany |
| L V Prasad Eye Institute | Hyderabaad | Andhra Pradesh | India |
| Consultant, Retina and Vitreous Services, Bhubaneswar L V Prasad Eye Institute | Bhubaneswar | Odisha | India |
| Department of Opthalmology, Sankara Nethralaya, Medical Research Foundation, | Chennai | Tamil Nadu | India |
| Aravind Eye Hospitals and Postgraduate Institute of Ophthalmology | Madurai | Tamil Nadu | India |
| Vittala International Institute of Ophthalmology | Bangalore | India |
| Advanced Eye Centre, Postgraduate Institute of Medical Education and Research (PGIMER) | Chandigarh | India |
| Aravind Eye Hospital, Uvea Clinic | Coimbatore | India |
| Aditya Jyot Eye Hospital Pvt Ltd | Mumbai | India |
| Dr. R. P. Centre for Ophthalmic Sciences, All India Institute of Medical Sciences | New Delhi | India |
| Bristol Eye Hospital and University of Bristol | Bristol | United Kingdom |
| Royal Liverpool University Hospital | Liverpool | United Kingdom |
| Moorfields Eye Hospital | London | United Kingdom |
| ID | Term |
|---|---|
| D015866 | Uveitis, Posterior |
| D015867 | Uveitis, Intermediate |
| D015864 | Panuveitis |
| D014605 | Uveitis |
| ID | Term |
|---|---|
| D014603 | Uveal Diseases |
| D005128 | Eye Diseases |
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