Clinical trial NCT00404742: A Study of LX211 in Clinically Quiescent Non-infectious Intermediate, Anterior and Intermediate, Posterior or Pan-Uveitis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Uveitis, Posterior
Uveitis, Intermediate
Panuveitis
Keywords: uveitis
calcineurin
Lead sponsor: Lux Biosciences, Inc.
Sponsor class: INDUSTRY
First posted: 2006-11-29
Enrollment: 232
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 clinically quiescent non-infectious uveitis


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:

* 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

Primary outcomes:
measure: recurrence of ocular inflammation
timeFrame: 26 weeks
Secondary outcomes:
measure: BCVA
timeFrame: 26 weeks
measure: systemic corticosteroid usage
timeFrame: 26 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: Indianapolis
country: United States
facility: Midwest Eye Institute
state: Indiana
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: Newark
country: United States
facility: UMDNJ-New Jersey Medical School, Ophthalmology Dept.
state: New Jersey
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: Arlington
country: United States
facility: Texas Retina Associates
state: Texas
city: Austin
country: United States
facility: Brian B. Berger, MD, P.A.
state: Texas
city: Dallas
country: United States
facility: Texas Retina Associates
state: Texas
city: Houston
country: United States
facility: Vitreoretinal Consultants
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: London
country: Canada
facility: Ivey Eye Institute
state: Ontario
city: Ottawa
country: Canada
facility: University of Ottawa Eye Institute
state: Ontario
city: Montreal
country: Canada
facility: McGill University Health Center
state: Quebec
city: Angers
country: France
facility: Center Hospitalier Universitaire d' Angers, Service d'Opthalmologie
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: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen
city: Hyderabaad
country: India
facility: L V Prasad Eye Institute
state: Andhra Pradesh
city: Bhubaneswar
country: India
facility: Consultant, Retina and Vitreous Services, Bhubaneswar L V Prasad Eye Institute
state: Orissa
city: Chennai
country: India
facility: Department of Opthalmology, Sankara Nethralaya, Medical Research Foundation,
state: Tamil Nadu
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: New Delhi
country: India
facility: Dr. R. P. Centre for Ophthalmic Sciences, All India Institute of Medical Sciences
city: Bristol
country: United Kingdom
facility: Bristol Eye Hospital and University of Bristol
city: Liverpool
country: United Kingdom
facility: Royal Liverpool University Hospital
city: London
country: United Kingdom
facility: Moorfields Eye Hospital
Study officials:
affiliation: Chief Medical Officer
name: Eddy Anglade, M.D.
role: STUDY_CHAIR
References: