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

NCT00404742 | Completed Phase 3 DMC

• 2 other identifiers: LX211-02-UVEudraCT No: 2006-006544-66
• Study Type: interventional
• Target: 232
• Locations: 7 countries
• Sites: 41

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

Conditions

Uveitis, Posterior; Uveitis, Intermediate; Panuveitis

Keywords

uveitis; calcineurin

Outcome Measures

Primary Outcomes (1)

• recurrence of ocular inflammation

  26 weeks

Secondary Outcomes (2)

• BCVA

  26 weeks

• systemic corticosteroid usage

  26 weeks

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

LX211, 0.2 mg/kg

ACTIVE COMPARATOR

Drug: LX211

LX211, 0.4 mg/kg

ACTIVE COMPARATOR

Drug: LX211

LX211, 0.6 mg/kg

ACTIVE COMPARATOR

Drug: LX211

Interventions

Placebo DRUG

PO BID

Placebo

LX211 DRUG

0.2 mg/kg, twice a day (BID)

LX211, 0.2 mg/kg

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lux Biosciences, Inc.: lead

Study Sites (41)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Location

Retinal Consultants of Arizona

Phoenix, Arizona, 85014, United States

Location

University of Illinois - Chicago

Chicago, Illinois, 60612, United States

Location

Midwest Eye Institute

Indianapolis, Indiana, 46280, United States

Location

Wilmer Eye Institute

Baltimore, Maryland, United States

Location

Massachusetts Eye and Ear Infirmary

Boston, Massachusetts, United States

Location

Massachusetts Eye Research and Surgery Institute

Cambridge, Massachusetts, 02142, United States

Location

Associated Retinal Consultants, PC

Grand Rapids, Michigan, 49546, United States

Location

Tauber Eye Center

Kansas City, Missouri, 64111, United States

Location

UMDNJ-New Jersey Medical School, Ophthalmology Dept.

Newark, New Jersey, 07103, United States

Location

New York Eye & Ear Hospital

New York, New York, 10003, United States

Location

Duke University Eye Center, Erwin Road

Durham, North Carolina, United States

Location

Oregon Health Sciences University

Portland, Oregon, 97201, United States

Location

Texas Retina Associates

Arlington, Texas, 76012, United States

Location

Brian B. Berger, MD, P.A.

Austin, Texas, 78705, United States

Location

Texas Retina Associates

Dallas, Texas, 75231, United States

Location

Vitreoretinal Consultants

Houston, Texas, 77030, United States

Location

Retina & Uveitis Consultants of Texas

San Antonio, Texas, 78240, United States

Location

Viginia Eye Consultants

Norfolk, Virginia, 23502, United States

Location

Universitätsklinik für Augenheilkunde

Salzburg, Austria

Location

Klinik für Augenheilkunde, Dept. of Ophthalmology

Vienna, Austria

Location

Ivey Eye Institute

London, Ontario, N6A 4G5, Canada

Location

University of Ottawa Eye Institute

Ottawa, Ontario, K1H 8L6, Canada

Location

McGill University Health Center

Montreal, Quebec, H3A 1A1, Canada

Location

Center Hospitalier Universitaire d' Angers, Service d'Opthalmologie

Angers, France

Location

Hôpital Pitié Salpétrière, Service d'Ophtalmologie

Paris, France

Location

Universitätsklinikum Freiburg

Freiburg im Breisgau, Germany

Location

Augenklinik der Universität Heidelberg

Heidelberg, Germany

Location

Universitätsklinikum Tübingen

Tübingen, Germany

Location

L V Prasad Eye Institute

Hyderabaad, Andhra Pradesh, India

Location

Consultant, Retina and Vitreous Services, Bhubaneswar L V Prasad Eye Institute

Bhubaneswar, Odisha, India

Location

Department of Opthalmology, Sankara Nethralaya, Medical Research Foundation,

Chennai, Tamil Nadu, India

Location

Aravind Eye Hospitals and Postgraduate Institute of Ophthalmology

Madurai, Tamil Nadu, India

Location

Vittala International Institute of Ophthalmology

Bangalore, India

Location

Advanced Eye Centre, Postgraduate Institute of Medical Education and Research (PGIMER)

Chandigarh, India

Location

Aravind Eye Hospital, Uvea Clinic

Coimbatore, India

Location

Aditya Jyot Eye Hospital Pvt Ltd

Mumbai, India

Location

Dr. R. P. Centre for Ophthalmic Sciences, All India Institute of Medical Sciences

New Delhi, India

Location

Bristol Eye Hospital and University of Bristol

Bristol, United Kingdom

Location

Royal Liverpool University Hospital

Liverpool, United Kingdom

Location

Moorfields Eye Hospital

London, United Kingdom

Location

Related Links

• Related Info

MeSH Terms

Conditions

Uveitis, Posterior; Uveitis, Intermediate; Panuveitis; Uveitis

Condition Hierarchy (Ancestors)

Uveal Diseases; Eye Diseases

Study Officials

• Eddy Anglade, M.D.

  Chief Medical Officer

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2006
• First Posted: November 29, 2006
• Study Start: January 1, 2007
• Primary Completion: November 1, 2008
• Study Completion: May 1, 2009
• Last Updated: June 22, 2012

Record last verified: 2012-06

Locations

US (19); FR (2); IN (9); CA (3); GB (3); DE (3); AU (2)