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A Study of LX211 in Clinically Quiescent Non-infectious Intermediate, Anterior and Intermediate, Posterior or Pan-Uveitis (LUMINATE)

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.
ClinicalTrials.gov Identifier: NCT00404742
Recruitment Status : Completed
First Posted : November 29, 2006
Last Update Posted : June 22, 2012
Information provided by (Responsible Party):
Lux Biosciences, Inc.

Brief Summary:
The objective of this study is to evaluate the safety and efficacy of LX211 as therapy in subjects with clinically quiescent non-infectious uveitis

Condition or disease Intervention/treatment Phase
Uveitis, Posterior Uveitis, Intermediate Panuveitis Drug: Placebo Drug: LX211 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 232 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, Multi-Center, Parallel-Group, Dose-Ranging Study With an Optional Extension to Assess the Efficacy and Safety of LX211 as Therapy in Subjects With Clinically Quiescent Sight Threatening, Non-infectious Intermediate, Anterior and Intermediate, Posterior or Pan-Uveitis
Study Start Date : January 2007
Actual Primary Completion Date : November 2008
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Placebo

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)

Primary Outcome Measures :
  1. recurrence of ocular inflammation [ Time Frame: 26 weeks ]

Secondary Outcome Measures :
  1. BCVA [ Time Frame: 26 weeks ]
  2. systemic corticosteroid usage [ Time Frame: 26 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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:

    • systemic prednisone or equivalent averaging ≥ 10 mg/day
    • at least 2 periocular/intravitreal corticosteroid administrations for control of inflammatory disease within the previous 8 months (but not within 6 weeks of randomization).
    • at least one, but not more than 2 immunosuppressive drugs from among the following compounds: cyclosporine, tacrolimus, azathioprine, mycophenolate mofetil, methotrexate
  • 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:

  • Evidence of active, uncontrolled non-infectious uveitis
  • Periocular administration of corticosteroids within the previous 6 weeks.
  • Uveitis of infectious etiology
  • Uncontrolled glaucoma
  • Clinically suspected or confirmed central nervous system or ocular lymphoma
  • History or diagnosis of Behçet's disease
  • Primary diagnosis of anterior uveitis

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): NCT00404742

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Sponsors and Collaborators
Lux Biosciences, Inc.
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Study Chair: Eddy Anglade, M.D. Chief Medical Officer
Additional Information:
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Responsible Party: Lux Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT00404742    
Other Study ID Numbers: LX211-02-UV
EudraCT No: 2006-006544-66
First Posted: November 29, 2006    Key Record Dates
Last Update Posted: June 22, 2012
Last Verified: June 2012
Keywords provided by Lux Biosciences, Inc.:
Additional relevant MeSH terms:
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Uveitis, Posterior
Uveitis, Intermediate
Pars Planitis
Uveal Diseases
Eye Diseases
Choroid Diseases