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

This study has been completed.

Sponsored by: Lux Biosciences, Inc.
Information provided by: Lux Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT00404742
  Purpose

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 Intervention Phase
Uveitis, Posterior
Uveitis, Intermediate
Panuveitis
Drug: LX211
Phase III

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Lux Biosciences, Inc.:

Primary Outcome Measures:
  • recurrence of ocular inflammation

Secondary Outcome Measures:
  • vitreous haze
  • anterior chamber cells
  • BCVA
  • systemic corticosteroid usage

Study Start Date:   January 2007
Primary Completion Date:   May 2008 (Final data collection date for primary outcome measure)

  Eligibility
Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00404742

Show 42 study locations  Show 42 Study Locations

Sponsors and Collaborators
Lux Biosciences, Inc.
  More Information

Related Info  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   LX211-02-UV, EudraCT No: 2006-006544-66
First Received:   November 27, 2006
Last Updated:   July 8, 2008
ClinicalTrials.gov Identifier:   NCT00404742
Health Authority:   United States: Food and Drug Administration

Keywords provided by Lux Biosciences, Inc.:
uveitis  
calcineurin  

Study placed in the following topic categories:
Panuveitis
Uveitis, Intermediate
Uveitis, Posterior
Uveitis
Eye Diseases

Additional relevant MeSH terms:
Uveal Diseases

ClinicalTrials.gov processed this record on September 04, 2008




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