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

Uveitis, Posterior Clinical Trial

— LUMINATE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00404742
• Other study ID #: LX211-02-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 clinically quiescent non-infectious uveitis

Recruitment information / eligibility

• Status: Completed
• Enrollment: 232
• 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:

• 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

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

• Panuveitis
• Uveitis
• Uveitis, Intermediate
• Uveitis, Posterior

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	Ivey Eye Institute	London	Ontario
Canada	McGill University Health Center	Montreal	Quebec
Canada	University of Ottawa Eye Institute	Ottawa	Ontario
France	Center Hospitalier Universitaire d' Angers, Service d'Opthalmologie	Angers
France	Hôpital Pitié Salpétrière, Service d'Ophtalmologie	Paris
Germany	Universitätsklinikum Freiburg	Freiburg
Germany	Augenklinik der Universität Heidelberg	Heidelberg
Germany	Universitätsklinikum Tübingen	Tübingen
India	Vittala International Institute of Ophthalmology	Bangalore
India	Consultant, Retina and Vitreous Services, Bhubaneswar L V Prasad Eye Institute	Bhubaneswar	Orissa
India	Advanced Eye Centre, Postgraduate Institute of Medical Education and Research (PGIMER)	Chandigarh
India	Department of Opthalmology, Sankara Nethralaya, Medical Research Foundation,	Chennai	Tamil Nadu
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
India	Dr. R. P. Centre for Ophthalmic Sciences, All India Institute of Medical Sciences	New Delhi
United Kingdom	Bristol Eye Hospital and University of Bristol	Bristol
United Kingdom	Royal Liverpool University Hospital	Liverpool
United Kingdom	Moorfields Eye Hospital	London
United States	Texas Retina Associates	Arlington	Texas
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	Texas Retina Associates	Dallas	Texas
United States	Duke University Eye Center, Erwin Road	Durham	North Carolina
United States	Associated Retinal Consultants, PC	Grand Rapids	Michigan
United States	Vitreoretinal Consultants	Houston	Texas
United States	Midwest Eye Institute	Indianapolis	Indiana
United States	Tauber Eye Center	Kansas City	Missouri
United States	New York Eye & Ear Hospital	New York	New York
United States	UMDNJ-New Jersey Medical School, Ophthalmology Dept.	Newark	New Jersey
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	recurrence of ocular inflammation		26 weeks	No
Secondary	BCVA		26 weeks	No
Secondary	systemic corticosteroid usage		26 weeks	No

External Links

•   Link