A Study of LX211 in Active Sight Threatening, 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: NCT00404612
• 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 active 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: 2012-10
• Last Update Submitted: 2012-10-09
• Last Update Posted: 2012-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 218

Inclusion Criteria

• Documented history of non-infectious intermediate-, anterior and intermediate-, posterior- or panuveitis uveitis

• Current uveitis therapy must conform to one of the following:

  1. Prednisone monotherapy at a dose of ≥ 10 mg/day (or equivalent) for ≥ 2 weeks prior to randomization
  2. Have received ≥ 2 injections of corticosteroid (intravitreal or periocular) for control of disease within the past 8 months, but not within 2 weeks of randomization; subjects may also be receiving systemic corticosteroid therapy
  3. Receiving monotherapy with azathioprine, mycophenolate mofetil, mycophenolic acid or methotrexate for at least 2 weeks prior to randomization
  4. Receiving prednisone in addition to one immunomodulatory agent from among cyclosporine, tacrolimus, azathioprine, mycophenolate mofetil, mycophenolic acid and methotrexate for at least 2 weeks prior to randomization
  5. Subjects for whom corticosteroid therapy (systemic or local) is medically inappropriate or who refuse corticosteroid therapy

• Grade of 2+ or higher for vitreous haze at time of enrollment

• Considered by the investigator to require immunomodulatory therapy.

• Not planning to undergo elective ocular surgery during the study

Exclusion Criteria

• Uveitis of infectious etiology
• Clinically suspected or confirmed central nervous system or ocular lymphoma
• 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
vitreous haze	16 and 24 weeks

Secondary Outcome Measures

Name	Time	Method
BCVA	24 weeks

Trial Locations

Locations (40)

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

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

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

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

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

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

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

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

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

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

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

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

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

Retina Research Center; 🇺🇸 Austin, Texas, United States

Ivey Eye Institute; 🇨🇦 London, Ontario, Canada

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

Universitätsklinik für Augenheilkunde; 🇦🇹 Salzburg, Austria

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

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

Universitätsklinikum Tübingen; 🇩🇪 Tübingen, Germany

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

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

Vitreoretinal Consultants; 🇺🇸 Houston, Texas, United States

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

Augenklinik der Universität Heidelberg; 🇩🇪 Heidelberg, Germany

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

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

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

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

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

Vittala International Institute of Ophthalmology; 🇮🇳 Bangalore, India

Moorfields Eye Hospital; 🇬🇧 London, United Kingdom

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

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

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

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

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

Royal Liverpool University Hospital; 🇬🇧 Liverpool, United Kingdom