A Study of LX211 in Clinically Quiescent Non-Infectious Intermediate, Anterior and Intermediate, Posterior or Pan-Uveitis - Full Text View

Purpose

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

Condition	Intervention	Phase
Uveitis, Posterior Uveitis, Intermediate Panuveitis	Drug: LX211	Phase III

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	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

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

Primary Outcome Measures:

Secondary Outcome Measures:

Study Start Date:	January 2007
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Eligibility

Criteria

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:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00404742

Sponsors and Collaborators

Lux Biosciences, Inc.

More Information

Related Info This link exits the ClinicalTrials.gov site

Study ID Numbers:	LX211-02-UV, EudraCT No: 2006-006544-66
First Received:	November 27, 2006
Last Updated:	July 8, 2008
ClinicalTrials.gov Identifier:	NCT00404742
Health Authority:	United States: Food and Drug Administration

Keywords provided by Lux Biosciences, Inc.:

uveitis

calcineurin

Study placed in the following topic categories:

Panuveitis

Uveitis, Intermediate

Uveitis, Posterior

Uveitis

Eye Diseases

Additional relevant MeSH terms:

Uveal Diseases

ClinicalTrials.gov processed this record on September 04, 2008

Sponsored by:	Lux Biosciences, Inc.
Information provided by:	Lux Biosciences, Inc.
ClinicalTrials.gov Identifier:	NCT00404742