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:
Information provided by (Responsible Party):
Lux Biosciences, Inc.
ClinicalTrials.gov Identifier:
NCT00404885
First received: November 27, 2006
Last updated: June 21, 2012
Last verified: June 2012
  Purpose

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 Intervention Phase
Uveitis, Anterior
Panuveitis
Drug: Placebo
Drug: LX211
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • anterior chamber cells [ Time Frame: 16 and 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • BCVA [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • macular thickness [ Time Frame: 16 and 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 108
Study Start Date: January 2007
Study Completion Date: May 2009
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: Lux Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT00404885     History of Changes
Other Study ID Numbers: LX211-03-UV, EudraCT No: 2006-006545-13
Study First Received: November 27, 2006
Last Updated: June 21, 2012
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Panuveitis
Uveitis
Chorioretinitis
Uveitis, Anterior
Iridocyclitis
Uveal Diseases
Eye Diseases
Retinitis
Retinal Diseases
Choroiditis
Choroid Diseases
Uveitis, Posterior
Iris Diseases

ClinicalTrials.gov processed this record on August 18, 2014