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

This study has been completed.
Information provided by (Responsible Party):
Lux Biosciences, Inc. Identifier:
First received: November 27, 2006
Last updated: June 21, 2012
Last verified: June 2012
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
Intervention Model: Parallel Assignment
Masking: Double Blind (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

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 ]

Secondary Outcome Measures:
  • BCVA [ Time Frame: 24 weeks ]
  • macular thickness [ Time Frame: 16 and 24 weeks ]

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
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)


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

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 identifier: NCT00404885

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

Additional Information:
Responsible Party: Lux Biosciences, Inc. 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

Keywords provided by Lux Biosciences, Inc.:

Additional relevant MeSH terms:
Uveitis, Anterior
Uveal Diseases
Eye Diseases
Iris Diseases processed this record on August 16, 2017