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A Multi-center Study to Assess the Efficacy and Safety of LX211 in Active Non-infectious Anterior Uveitis (LUMINATE)

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ClinicalTrials.gov Identifier: NCT00404885
Recruitment Status : Completed
First Posted : November 29, 2006
Last Update Posted : June 22, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Uveitis, Anterior Panuveitis Drug: Placebo Drug: LX211 Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : January 2007
Primary Completion Date : November 2008
Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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)


Outcome Measures

Primary Outcome Measures :
  1. anterior chamber cells [ Time Frame: 16 and 24 weeks ]

Secondary Outcome Measures :
  1. BCVA [ Time Frame: 24 weeks ]
  2. macular thickness [ Time Frame: 16 and 24 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00404885


  Show 30 Study Locations
Sponsors and Collaborators
Lux Biosciences, Inc.
Investigators
Study Chair: Eddy Anglade, M.D. Chief Medical Officer
More Information

Additional Information:
Responsible Party: Lux Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT00404885     History of Changes
Other Study ID Numbers: LX211-03-UV
EudraCT No: 2006-006545-13
First Posted: November 29, 2006    Key Record Dates
Last Update Posted: June 22, 2012
Last Verified: June 2012

Keywords provided by Lux Biosciences, Inc.:
uveitis
calcineurin
inflammation

Additional relevant MeSH terms:
Uveitis
Uveitis, Anterior
Iridocyclitis
Panuveitis
Uveal Diseases
Eye Diseases
Iris Diseases