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A Study of LX211 in Active Sight Threatening, 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: NCT00404612
  Purpose

The objective of this study is to evaluate the safety and efficacy of LX211 as therapy in subjects with active 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 (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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 Intermediate-, Anterior and Intermediate-, Posterior-, or Pan-Uveitis

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

Primary Outcome Measures:
  • vitreous haze [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • corticosteroid use
  • BCVA [ Designated as safety issue: Yes ]

Estimated Enrollment: 210
Study Start Date: January 2007
Primary Completion Date: June 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:

  • Documented history of non-infectious intermediate-, anterior and intermediate-, posterior- or panuveitis uveitis
  • Current uveitis therapy must conform to one of the following:

    1. Prednisone monotherapy at a dose of ≥ 10 mg/day (or equivalent) for ≥ 2 weeks prior to randomization
    2. Have received ≥ 2 injections of corticosteroid (intravitreal or periocular) for control of disease within the past 8 months, but not within 2 weeks of randomization; subjects may also be receiving systemic corticosteroid therapy
    3. Receiving monotherapy with azathioprine, mycophenolate mofetil, mycophenolic acid or methotrexate for at least 2 weeks prior to randomization
    4. Receiving prednisone in addition to one immunomodulatory agent from among cyclosporine, tacrolimus, azathioprine, mycophenolate mofetil, mycophenolic acid and methotrexate for at least 2 weeks prior to randomization
    5. Subjects for whom corticosteroid therapy (systemic or local) is medically inappropriate or who refuse corticosteroid therapy
  • Grade of 2+ or higher for vitreous haze at time of enrollment
  • Considered by the investigator to require immunomodulatory therapy.
  • Not planning to undergo elective ocular surgery during the study

Exclusion Criteria:

  • Uveitis of infectious etiology
  • Clinically suspected or confirmed central nervous system or ocular lymphoma
  • Primary diagnosis of anterior uveitis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00404612

  Show 43 Study Locations
Sponsors and Collaborators
Lux Biosciences, Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Lux Biosciences, Inc. ( Dr. Cathy Stein-Izsak )
Study ID Numbers: LX211-01-UV, EudraCT No: 2006-006543-31
Study First Received: November 27, 2006
Last Updated: July 8, 2008
ClinicalTrials.gov Identifier: NCT00404612  
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 February 12, 2009