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

June 21, 2012 updated by: Lux Biosciences, Inc.

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

The objective of this study is to evaluate the safety and efficacy of LX211 as therapy in subjects with active non-infectious anterior uveitis

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

108

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Salzburg, Austria
        • Universitätsklinik für Augenheilkunde
      • Wien, Austria
        • Klinik für Augenheilkunde, Dept. of Ophthalmology
  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H3A 1A1
        • McGill University Health Center
  • France
      • Paris, France
        • Hôpital Pitié Salpétrière, Service d'Ophtalmologie
  • Germany
      • Freiburg, Germany
        • Universitätsklinikum Freiburg
      • Heidelberg, Germany
        • Augenklinik der Universität Heidelberg
      • Münster, Germany
        • St. Franziskus-Hospital
      • Tübingen, Germany
        • Universitätsklinikum Tübingen
  • India
      • Bangalore, India
        • Vittala International Institute of Ophthalmology
      • Chandigarh, India
        • Advanced Eye Centre, Postgraduate Institute of Medical Education and Research (PGIMER)
      • Coimbatore, India
        • Aravind Eye Hospital, Uvea Clinic
      • Mumbai, India
        • Aditya Jyot Eye Hospital Pvt Ltd
    • Andhra Pradesh
      • Hyderabaad, Andhra Pradesh, India
        • L V Prasad Eye Institute
    • Tamil Nadu
      • Madurai, Tamil Nadu, India
        • Aravind Eye Hospitals and Postgraduate Institute of Ophthalmology
  • United Kingdom
      • Bristol, United Kingdom
        • Bristol Eye Hospital and University of Bristol
      • Liverpool, United Kingdom
        • Royal Liverpool University Hospital
  • United States
    • Alabama
      • Birmingham, Alabama, United States
        • University of Alabama at Birmingham
    • Arizona
      • Phoenix, Arizona, United States, 85014
        • Retinal Consultants of Arizona
    • Illinois
      • Chicago, Illinois, United States, 60612
        • University of Illinois - Chicago
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Wilmer Eye Institute
    • Massachusetts
      • Boston, Massachusetts, United States
        • Massachusetts Eye and Ear Infirmary
      • Cambridge, Massachusetts, United States, 02142
        • Massachusetts Eye Research and Surgery Institute
    • Michigan
      • Grand Rapids, Michigan, United States, 49546
        • Associated Retinal Consultants, PC
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Tauber Eye Center
    • New York
      • New York, New York, United States, 10003
        • New York Eye & Ear Hospital
    • North Carolina
      • Durham, North Carolina, United States
        • Duke University Eye Center, Erwin Road
    • Oregon
      • Portland, Oregon, United States, 97201
        • Oregon Health Sciences University
    • Texas
      • Austin, Texas, United States, 78705
        • Brian B. Berger, MD, P.A.
      • San Antonio, Texas, United States, 78240
        • Retina & Uveitis Consultants of Texas
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Viginia Eye Consultants

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
PO BID
Active Comparator: LX211, 0.2 mg/kg
Drug: LX211
0.2 mg/kg, twice a day (BID)
Drug: LX211
0.4 mg/kg, twice a day (BID)
Drug: LX211
0.6 mg/kg, twice a day (BID)
Active Comparator: LX211, 0.4 mg/kg
Drug: LX211
0.2 mg/kg, twice a day (BID)
Drug: LX211
0.4 mg/kg, twice a day (BID)
Drug: LX211
0.6 mg/kg, twice a day (BID)
Active Comparator: LX211, 0.6 mg/kg
Drug: LX211
0.2 mg/kg, twice a day (BID)
Drug: LX211
0.4 mg/kg, twice a day (BID)
Drug: LX211
0.6 mg/kg, twice a day (BID)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
anterior chamber cells
Time Frame: 16 and 24 weeks
16 and 24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
BCVA
Time Frame: 24 weeks
24 weeks
macular thickness
Time Frame: 16 and 24 weeks
16 and 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lux Biosciences, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

November 1, 2008

Study Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

November 27, 2006

First Submitted That Met QC Criteria

November 27, 2006

First Posted (Estimate)

November 29, 2006

Study Record Updates

Last Update Posted (Estimate)

June 22, 2012

Last Update Submitted That Met QC Criteria

June 21, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LX211-03-UV
  • EudraCT No: 2006-006545-13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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