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

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

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

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

Study Overview

Study Type

Interventional

Enrollment (Actual)

232

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

      • Salzburg, Austria
        • Universitätsklinik für Augenheilkunde
      • Wien, Austria
        • Klinik für Augenheilkunde, Dept. of Ophthalmology
    • Ontario
      • London, Ontario, Canada, N6A 4G5
        • Ivey Eye Institute
      • Ottawa, Ontario, Canada, K1H 8L6
        • University of Ottawa Eye Institute
    • Quebec
      • Montreal, Quebec, Canada, H3A 1A1
        • McGill University Health Center
      • Angers, France
        • Center Hospitalier Universitaire d' Angers, Service d'Opthalmologie
      • Paris, France
        • Hôpital Pitié Salpétrière, Service d'Ophtalmologie
      • Freiburg, Germany
        • Universitatsklinikum Freiburg
      • Heidelberg, Germany
        • Augenklinik der Universität Heidelberg
      • Tübingen, Germany
        • Universitatsklinikum Tubingen
      • 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
      • New Delhi, India
        • Dr. R. P. Centre for Ophthalmic Sciences, All India Institute of Medical Sciences
    • Andhra Pradesh
      • Hyderabaad, Andhra Pradesh, India
        • L V Prasad Eye Institute
    • Orissa
      • Bhubaneswar, Orissa, India
        • Consultant, Retina and Vitreous Services, Bhubaneswar L V Prasad Eye Institute
    • Tamil Nadu
      • Chennai, Tamil Nadu, India
        • Department of Opthalmology, Sankara Nethralaya, Medical Research Foundation,
      • Madurai, Tamil Nadu, India
        • Aravind Eye Hospitals and Postgraduate Institute of Ophthalmology
      • Bristol, United Kingdom
        • Bristol Eye Hospital and University of Bristol
      • Liverpool, United Kingdom
        • Royal Liverpool University Hospital
      • London, United Kingdom
        • Moorfields Eye Hospital
    • 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
    • Indiana
      • Indianapolis, Indiana, United States, 46280
        • Midwest Eye Institute
    • Maryland
      • Baltimore, Maryland, United States
        • 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 Jersey
      • Newark, New Jersey, United States, 07103
        • UMDNJ-New Jersey Medical School, Ophthalmology Dept.
    • 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
      • Arlington, Texas, United States, 76012
        • Texas Retina Associates
      • Austin, Texas, United States, 78705
        • Brian B. Berger, MD, P.A.
      • Dallas, Texas, United States, 75231
        • Texas Retina Associates
      • Houston, Texas, United States, 77030
        • Vitreoretinal Consultants
      • 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:

  • 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

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
PO BID
Active Comparator: LX211, 0.2 mg/kg
0.2 mg/kg, twice a day (BID)
0.4 mg/kg, twice a day (BID)
0.6 mg/kg, twice a day (BID)
Active Comparator: LX211, 0.4 mg/kg
0.2 mg/kg, twice a day (BID)
0.4 mg/kg, twice a day (BID)
0.6 mg/kg, twice a day (BID)
Active Comparator: LX211, 0.6 mg/kg
0.2 mg/kg, twice a day (BID)
0.4 mg/kg, twice a day (BID)
0.6 mg/kg, twice a day (BID)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
recurrence of ocular inflammation
Time Frame: 26 weeks
26 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
BCVA
Time Frame: 26 weeks
26 weeks
systemic corticosteroid usage
Time Frame: 26 weeks
26 weeks

Collaborators and Investigators

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

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

Other Study ID Numbers

  • LX211-02-UV
  • EudraCT No: 2006-006544-66

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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