A Multi-center Study to Assess the Efficacy and Safety of LX211 in Active Non-infectious Anterior Uveitis (LUMINATE)
This study has been completed.
Sponsor:
Lux Biosciences, Inc.
Information provided by (Responsible Party):
Lux Biosciences, Inc.
ClinicalTrials.gov Identifier:
NCT00404885
First received: November 27, 2006
Last updated: June 21, 2012
Last verified: June 2012
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Purpose
The objective of this study is to evaluate the safety and efficacy of LX211 as therapy in subjects with active non-infectious anterior uveitis
| Condition | Intervention | Phase |
|---|---|---|
|
Uveitis, Anterior Panuveitis |
Drug: Placebo Drug: LX211 |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Double-Masked, Placebo-Controlled, Parallel-Group, Multi-Center, Dose-Ranging Study With an Optional Extension to Assess the Efficacy and Safety of LX211 as Therapy in Subjects With Active Sight Threatening, Non-infectious Anterior Uveitis |
Further study details as provided by Lux Biosciences, Inc.:
Primary Outcome Measures:
- anterior chamber cells [ Time Frame: 16 and 24 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- BCVA [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- macular thickness [ Time Frame: 16 and 24 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 108 |
| Study Start Date: | January 2007 |
| Study Completion Date: | May 2009 |
| Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: Placebo |
Drug: Placebo
PO BID
|
| Active Comparator: LX211, 0.2 mg/kg |
Drug: LX211
0.2 mg/kg, twice a day (BID)
|
| Active Comparator: LX211, 0.4 mg/kg |
Drug: LX211
0.4 mg/kg, twice a day (BID)
|
| Active Comparator: LX211, 0.6 mg/kg |
Drug: LX211
0.6 mg/kg, twice a day (BID)
|
Eligibility| Ages Eligible for Study: | 13 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Documented history of non-infectious anterior, anterior and intermediate- or panuveitis
- Currently uncontrolled uveitis for a minimum of 2 weeks despite use of oral and/or topical corticosteroid,or subjects who are intolerant of local corticosteroid therapy due to the development of an ocular hypertensive response or subjects for whom oral corticosteroid is contraindicated.
- Grade of 2+ or higher for anterior chamber cells at time of enrollment
- Considered by the investigator to require corticosteroid-sparing therapy.
- Subjects not planning to undergo elective ocular surgery during the study
Exclusion Criteria:
- Uveitis of infectious etiology
- Presence of an ocular toxoplasmosis scar
- An immune suppression regimen that includes an alkylating agent within the previous 90 days
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00404885
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Hide Study LocationsLocations
| United States, Alabama | |
| University of Alabama at Birmingham | |
| Birmingham, Alabama, United States | |
| United States, Arizona | |
| Retinal Consultants of Arizona | |
| Phoenix, Arizona, United States, 85014 | |
| United States, Illinois | |
| University of Illinois - Chicago | |
| Chicago, Illinois, United States, 60612 | |
| United States, Maryland | |
| Wilmer Eye Institute | |
| Baltimore, Maryland, United States, 21287 | |
| United States, Massachusetts | |
| Massachusetts Eye and Ear Infirmary | |
| Boston, Massachusetts, United States | |
| Massachusetts Eye Research and Surgery Institute | |
| Cambridge, Massachusetts, United States, 02142 | |
| United States, Michigan | |
| Associated Retinal Consultants, PC | |
| Grand Rapids, Michigan, United States, 49546 | |
| United States, Missouri | |
| Tauber Eye Center | |
| Kansas City, Missouri, United States, 64111 | |
| United States, New York | |
| New York Eye & Ear Hospital | |
| New York, New York, United States, 10003 | |
| United States, North Carolina | |
| Duke University Eye Center, Erwin Road | |
| Durham, North Carolina, United States | |
| United States, Oregon | |
| Oregon Health Sciences University | |
| Portland, Oregon, United States, 97201 | |
| United States, Texas | |
| Brian B. Berger, MD, P.A. | |
| Austin, Texas, United States, 78705 | |
| Retina & Uveitis Consultants of Texas | |
| San Antonio, Texas, United States, 78240 | |
| United States, Virginia | |
| Viginia Eye Consultants | |
| Norfolk, Virginia, United States, 23502 | |
| Austria | |
| Universitätsklinik für Augenheilkunde | |
| Salzburg, Austria | |
| Klinik für Augenheilkunde, Dept. of Ophthalmology | |
| Wien, Austria | |
| Canada, Quebec | |
| McGill University Health Center | |
| Montreal, Quebec, Canada, H3A 1A1 | |
| France | |
| Hôpital Pitié Salpétrière, Service d'Ophtalmologie | |
| Paris, France | |
| Germany | |
| Universitätsklinikum Freiburg | |
| Freiburg, Germany | |
| Augenklinik der Universität Heidelberg | |
| Heidelberg, Germany | |
| St. Franziskus-Hospital | |
| Münster, Germany | |
| Universitätsklinikum Tübingen | |
| Tübingen, Germany | |
| India | |
| L V Prasad Eye Institute | |
| Hyderabaad, Andhra Pradesh, 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 | |
| United Kingdom | |
| Bristol Eye Hospital and University of Bristol | |
| Bristol, United Kingdom | |
| Royal Liverpool University Hospital | |
| Liverpool, United Kingdom | |
Sponsors and Collaborators
Lux Biosciences, Inc.
Investigators
| Study Chair: | Eddy Anglade, M.D. | Chief Medical Officer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Lux Biosciences, Inc. |
| ClinicalTrials.gov Identifier: | NCT00404885 History of Changes |
| Other Study ID Numbers: | LX211-03-UV, EudraCT No: 2006-006545-13 |
| Study First Received: | November 27, 2006 |
| Last Updated: | June 21, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Lux Biosciences, Inc.:
|
uveitis calcineurin inflammation |
Additional relevant MeSH terms:
|
Panuveitis Uveitis Chorioretinitis Uveitis, Anterior Iridocyclitis Uveal Diseases Eye Diseases |
Retinitis Retinal Diseases Choroiditis Choroid Diseases Uveitis, Posterior Iris Diseases |
ClinicalTrials.gov processed this record on June 17, 2013