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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:
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
  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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00404885

  Hide Study Locations
Locations
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:
Chorioretinitis
Iridocyclitis
Panuveitis
Uveitis
Uveitis, Anterior
Choroid Diseases
Choroiditis
Eye Diseases
Iris Diseases
Retinal Diseases
Retinitis
Uveal Diseases
Uveitis, Posterior

ClinicalTrials.gov processed this record on November 25, 2014