A Study of LX211 in Active Sight Threatening, Non-Infectious Intermediate-, Anterior and Intermediate-, Posterior-, or Pan-Uveitis - Full Text View

A Study of LX211 in Active Sight Threatening, Non-Infectious Intermediate-, Anterior and Intermediate-, Posterior-, or Pan-Uveitis (LUMINATE)

This study has been completed.

First Received on November 27, 2006. Last Updated on July 8, 2008 History of Changes

Sponsor:	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

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 Intermediate-, Anterior and Intermediate-, Posterior-, or Pan-Uveitis

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

Primary Outcome Measures:

Secondary Outcome Measures:

Estimated Enrollment:	210
Study Start Date:	January 2007
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Eligibility

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:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00404612

Sponsors and Collaborators

Lux Biosciences, Inc.

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Dr. Cathy Stein-Izsak, Lux Biosciences, Inc.
ClinicalTrials.gov Identifier:	NCT00404612 History of Changes
Other Study ID Numbers:	LX211-01-UV, EudraCT No: 2006-006543-31
Study First Received:	November 27, 2006
Last Updated:	July 8, 2008
Health Authority:	United States: Food and Drug Administration

Keywords provided by Lux Biosciences, Inc.:

uveitis
calcineurin

Additional relevant MeSH terms:

Panuveitis
Uveitis
Uveitis, Intermediate

Uveitis, Posterior
Uveal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on February 09, 2012