Clinical trial NCT00404885: A Multi-center Study to Assess the Efficacy and Safety of LX211 in Active Non-infectious Anterior Uveitis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Uveitis, Anterior
Panuveitis
Keywords: uveitis
calcineurin
inflammation
Lead sponsor: Lux Biosciences, Inc.
Sponsor class: INDUSTRY
First posted: 2006-11-29
Enrollment: 108
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: anterior chamber cells
timeFrame: 16 and 24 weeks
Secondary outcomes:
measure: BCVA
timeFrame: 24 weeks
measure: macular thickness
timeFrame: 16 and 24 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Phoenix
country: United States
facility: Retinal Consultants of Arizona
state: Arizona
city: Chicago
country: United States
facility: University of Illinois - Chicago
state: Illinois
city: Baltimore
country: United States
facility: Wilmer Eye Institute
state: Maryland
city: Boston
country: United States
facility: Massachusetts Eye and Ear Infirmary
state: Massachusetts
city: Cambridge
country: United States
facility: Massachusetts Eye Research and Surgery Institute
state: Massachusetts
city: Grand Rapids
country: United States
facility: Associated Retinal Consultants, PC
state: Michigan
city: Kansas City
country: United States
facility: Tauber Eye Center
state: Missouri
city: New York
country: United States
facility: New York Eye & Ear Hospital
state: New York
city: Durham
country: United States
facility: Duke University Eye Center, Erwin Road
state: North Carolina
city: Portland
country: United States
facility: Oregon Health Sciences University
state: Oregon
city: Austin
country: United States
facility: Brian B. Berger, MD, P.A.
state: Texas
city: San Antonio
country: United States
facility: Retina & Uveitis Consultants of Texas
state: Texas
city: Norfolk
country: United States
facility: Viginia Eye Consultants
state: Virginia
city: Salzburg
country: Austria
facility: Universitätsklinik für Augenheilkunde
city: Wien
country: Austria
facility: Klinik für Augenheilkunde, Dept. of Ophthalmology
city: Montreal
country: Canada
facility: McGill University Health Center
state: Quebec
city: Paris
country: France
facility: Hôpital Pitié Salpétrière, Service d'Ophtalmologie
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg
city: Heidelberg
country: Germany
facility: Augenklinik der Universität Heidelberg
city: Münster
country: Germany
facility: St. Franziskus-Hospital
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen
city: Hyderabaad
country: India
facility: L V Prasad Eye Institute
state: Andhra Pradesh
city: Madurai
country: India
facility: Aravind Eye Hospitals and Postgraduate Institute of Ophthalmology
state: Tamil Nadu
city: Bangalore
country: India
facility: Vittala International Institute of Ophthalmology
city: Chandigarh
country: India
facility: Advanced Eye Centre, Postgraduate Institute of Medical Education and Research (PGIMER)
city: Coimbatore
country: India
facility: Aravind Eye Hospital, Uvea Clinic
city: Mumbai
country: India
facility: Aditya Jyot Eye Hospital Pvt Ltd
city: Bristol
country: United Kingdom
facility: Bristol Eye Hospital and University of Bristol
city: Liverpool
country: United Kingdom
facility: Royal Liverpool University Hospital
Study officials:
affiliation: Chief Medical Officer
name: Eddy Anglade, M.D.
role: STUDY_CHAIR
References: