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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00404885
Other study ID # LX211-03-UV
Secondary ID EudraCT No: 2006
Status Completed
Phase Phase 3
First received November 27, 2006
Last updated June 21, 2012
Start date January 2007
Est. completion date May 2009

Study information

Verified date June 2012
Source Lux Biosciences, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 108
Est. completion date May 2009
Est. primary completion date November 2008
Accepts healthy volunteers No
Gender Both
Age group 13 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Placebo
PO BID
LX211
0.2 mg/kg, twice a day (BID)
LX211
0.4 mg/kg, twice a day (BID)
LX211
0.6 mg/kg, twice a day (BID)

Locations

Country Name City State
Austria Universitätsklinik für Augenheilkunde Salzburg
Austria Klinik für Augenheilkunde, Dept. of Ophthalmology Wien
Canada McGill University Health Center Montreal Quebec
France Hôpital Pitié Salpétrière, Service d'Ophtalmologie Paris
Germany Universitätsklinikum Freiburg Freiburg
Germany Augenklinik der Universität Heidelberg Heidelberg
Germany St. Franziskus-Hospital Münster
Germany Universitätsklinikum Tübingen Tübingen
India Vittala International Institute of Ophthalmology Bangalore
India Advanced Eye Centre, Postgraduate Institute of Medical Education and Research (PGIMER) Chandigarh
India Aravind Eye Hospital, Uvea Clinic Coimbatore
India L V Prasad Eye Institute Hyderabaad Andhra Pradesh
India Aravind Eye Hospitals and Postgraduate Institute of Ophthalmology Madurai Tamil Nadu
India Aditya Jyot Eye Hospital Pvt Ltd Mumbai
United Kingdom Bristol Eye Hospital and University of Bristol Bristol
United Kingdom Royal Liverpool University Hospital Liverpool
United States Brian B. Berger, MD, P.A. Austin Texas
United States Wilmer Eye Institute Baltimore Maryland
United States University of Alabama at Birmingham Birmingham Alabama
United States Massachusetts Eye and Ear Infirmary Boston Massachusetts
United States Massachusetts Eye Research and Surgery Institute Cambridge Massachusetts
United States University of Illinois - Chicago Chicago Illinois
United States Duke University Eye Center, Erwin Road Durham North Carolina
United States Associated Retinal Consultants, PC Grand Rapids Michigan
United States Tauber Eye Center Kansas City Missouri
United States New York Eye & Ear Hospital New York New York
United States Viginia Eye Consultants Norfolk Virginia
United States Retinal Consultants of Arizona Phoenix Arizona
United States Oregon Health Sciences University Portland Oregon
United States Retina & Uveitis Consultants of Texas San Antonio Texas

Sponsors (1)

Lead Sponsor Collaborator
Lux Biosciences, Inc.

Countries where clinical trial is conducted

United States,  Austria,  Canada,  France,  Germany,  India,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary anterior chamber cells 16 and 24 weeks No
Secondary BCVA 24 weeks No
Secondary macular thickness 16 and 24 weeks No
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Completed NCT00615693 - Safety, Tolerability, and Efficacy of AEB071 in the Treatment of Uveitis Phase 2
Completed NCT00404612 - A Study of LX211 in Active Sight Threatening, Non-infectious Intermediate-, Anterior and Intermediate-, Posterior-, or Pan-Uveitis Phase 3
Completed NCT00404742 - A Study of LX211 in Clinically Quiescent Non-infectious Intermediate, Anterior and Intermediate, Posterior or Pan-Uveitis Phase 3
Completed NCT01789320 - Safety Study of Suprachoroidal Triamcinolone Acetonide Via Microneedle to Treat Uveitis Phase 1/Phase 2
Completed NCT02952001 - MAGNOLIA: Extension Study of Patients With Non-infectious Uveitis Who Participated in CLS1001-301
Completed NCT00406887 - Study of Difluprednate Ophthalmic Emulsion in the Treatment of Uveitis Phase 3
Completed NCT00407056 - Study of Difluprednate Ophthalmic Emulsion in the Treatment of Severe Uveitis Phase 3
Completed NCT03097315 - Suprachoroidal Injection of CLS-TA in Patients With Non-infectious Uveitis Phase 3

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