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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:
ClinicalTrials.gov Identifier:
NCT00404885
First Posted: November 29, 2006
Last Update Posted: June 22, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Lux Biosciences, Inc.
November 27, 2006
November 29, 2006
June 22, 2012
January 2007
November 2008   (Final data collection date for primary outcome measure)
anterior chamber cells [ Time Frame: 16 and 24 weeks ]
Not Provided
Complete list of historical versions of study NCT00404885 on ClinicalTrials.gov Archive Site
  • BCVA [ Time Frame: 24 weeks ]
  • macular thickness [ Time Frame: 16 and 24 weeks ]
Not Provided
Not Provided
Not Provided
 
A Multi-center Study to Assess the Efficacy and Safety of LX211 in Active Non-infectious Anterior Uveitis
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
The objective of this study is to evaluate the safety and efficacy of LX211 as therapy in subjects with active non-infectious anterior uveitis
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Uveitis, Anterior
  • Panuveitis
  • Drug: Placebo
    PO BID
  • Drug: LX211
    0.2 mg/kg, twice a day (BID)
  • Drug: LX211
    0.4 mg/kg, twice a day (BID)
  • Drug: LX211
    0.6 mg/kg, twice a day (BID)
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Active Comparator: LX211, 0.2 mg/kg
    Intervention: Drug: LX211
  • Active Comparator: LX211, 0.4 mg/kg
    Intervention: Drug: LX211
  • Active Comparator: LX211, 0.6 mg/kg
    Intervention: Drug: LX211
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
108
May 2009
November 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
13 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Canada,   France,   Germany,   India,   United Kingdom,   United States
 
 
NCT00404885
LX211-03-UV
EudraCT No: 2006-006545-13
Yes
Not Provided
Not Provided
Lux Biosciences, Inc.
Lux Biosciences, Inc.
Not Provided
Study Chair: Eddy Anglade, M.D. Chief Medical Officer
Lux Biosciences, Inc.
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP