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

Phase 3

Completed

• Conditions: Uveitis, Posterior; Uveitis, Intermediate; Panuveitis
• Interventions: Drug: Placebo; Drug: LX211

• Registration Number: NCT00404742
• Lead Sponsor: Lux Biosciences, Inc.

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-11-27
• Study First Submitted QC: 2006-11-27
• Study First Posted: 2006-11-29
• Study Start: 2007-01
• Primary Completion: 2008-11
• Study Completion: 2009-05
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-21
• Last Update Posted: 2012-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 232

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
LX211, 0.4 mg/kg	LX211	-
LX211, 0.2 mg/kg	LX211	-
LX211, 0.6 mg/kg	LX211	-

Primary Outcome Measures

Name	Time	Method
recurrence of ocular inflammation	26 weeks

Secondary Outcome Measures

Name	Time	Method
BCVA	26 weeks
systemic corticosteroid usage	26 weeks

Trial Locations

Locations (40)

University of Illinois - Chicago; 🇺🇸 Chicago, Illinois, United States

Midwest Eye Institute; 🇺🇸 Indianapolis, Indiana, United States

Wilmer Eye Institute; 🇺🇸 Baltimore, Maryland, United States

UMDNJ-New Jersey Medical School, Ophthalmology Dept.; 🇺🇸 Newark, New Jersey, United States

Duke University Eye Center, Erwin Road; 🇺🇸 Durham, North Carolina, United States

Texas Retina Associates; 🇺🇸 Dallas, Texas, United States

Retina & Uveitis Consultants of Texas; 🇺🇸 San Antonio, Texas, United States

Aravind Eye Hospitals and Postgraduate Institute of Ophthalmology; 🇮🇳 Madurai, Tamil Nadu, India

Department of Opthalmology, Sankara Nethralaya, Medical Research Foundation,; 🇮🇳 Chennai, Tamil Nadu, India

Retinal Consultants of Arizona; 🇺🇸 Phoenix, Arizona, United States

Klinik für Augenheilkunde, Dept. of Ophthalmology; 🇦🇹 Wien, Austria

Vittala International Institute of Ophthalmology; 🇮🇳 Bangalore, India

Massachusetts Eye and Ear Infirmary; 🇺🇸 Boston, Massachusetts, United States

McGill University Health Center; 🇨🇦 Montreal, Quebec, Canada

L V Prasad Eye Institute; 🇮🇳 Hyderabaad, Andhra Pradesh, India

Universitätsklinik für Augenheilkunde; 🇦🇹 Salzburg, Austria

Advanced Eye Centre, Postgraduate Institute of Medical Education and Research (PGIMER); 🇮🇳 Chandigarh, India

Massachusetts Eye Research and Surgery Institute; 🇺🇸 Cambridge, Massachusetts, United States

Associated Retinal Consultants, PC; 🇺🇸 Grand Rapids, Michigan, United States

Oregon Health Sciences University; 🇺🇸 Portland, Oregon, United States

Tauber Eye Center; 🇺🇸 Kansas City, Missouri, United States

Ivey Eye Institute; 🇨🇦 London, Ontario, Canada

Brian B. Berger, MD, P.A.; 🇺🇸 Austin, Texas, United States

Viginia Eye Consultants; 🇺🇸 Norfolk, Virginia, United States

Vitreoretinal Consultants; 🇺🇸 Houston, Texas, United States

Augenklinik der Universität Heidelberg; 🇩🇪 Heidelberg, Germany

Universitätsklinikum Tübingen; 🇩🇪 Tübingen, Germany

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

New York Eye & Ear Hospital; 🇺🇸 New York, New York, United States

University of Ottawa Eye Institute; 🇨🇦 Ottawa, Ontario, Canada

Center Hospitalier Universitaire d' Angers, Service d'Opthalmologie; 🇫🇷 Angers, France

Hôpital Pitié Salpétrière, Service d'Ophtalmologie; 🇫🇷 Paris, France

Consultant, Retina and Vitreous Services, Bhubaneswar L V Prasad Eye Institute; 🇮🇳 Bhubaneswar, Orissa, India

Universitätsklinikum Freiburg; 🇩🇪 Freiburg, Germany

Aditya Jyot Eye Hospital Pvt Ltd; 🇮🇳 Mumbai, India

Aravind Eye Hospital, Uvea Clinic; 🇮🇳 Coimbatore, India

Dr. R. P. Centre for Ophthalmic Sciences, All India Institute of Medical Sciences; 🇮🇳 New Delhi, India

Bristol Eye Hospital and University of Bristol; 🇬🇧 Bristol, United Kingdom

Moorfields Eye Hospital; 🇬🇧 London, United Kingdom

Royal Liverpool University Hospital; 🇬🇧 Liverpool, United Kingdom