Clinical Trials Logo

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


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
See also
  Status Clinical Trial Phase
Completed NCT00570479 - Prophylactic Anecortave Acetate in Patients With a Retisert Implant Phase 1
Recruiting NCT05486468 - The Use of Two YUTIQ Versus Sham for Treatment of Chronic Non Infectious Intraocular Inflammation Affecting the Posterior Segment Phase 3
Terminated NCT03656692 - Safety and Effectiveness of Acthar Gel for Inflammation of the Eye's Uvea (Middle Layer) Phase 4
Completed NCT02255032 - Suprachoroidal Injection of Triamcinolone Acetonide in Subjects With Macular Edema Following Non-Infectious Uveitis Phase 2
Completed NCT00035906 - Research Study in Patients With Persistent Macular Edema Phase 2
Recruiting NCT05101928 - Ozurdex Monotherapy Trial Phase 4
Terminated NCT05070728 - Safety and Efficacy of an Injectable Fluocinolone Acetonide Intravitreal Insert (FAI) Phase 3
Completed NCT02595398 - Suprachoroidal Injection of CLS-TA in Subjects With Macular Edema Associated With Non-infectious Uveitis Phase 3
Recruiting NCT03066869 - Efficacy and Safety of H.P. ACTHAR GEL in Adults With Retinal Vasculitis Phase 4
Completed NCT01539577 - A Long-Term Safety Study of OZURDEX® in Clinical Practice N/A
Recruiting NCT05322070 - Fluocinolone Acetonide Intravitreal Implant 0.18 mg in the Treatment of Chronic Non-Infectious Posterior Segment Uveitis Phase 4
Recruiting NCT06085079 - Ixekizumab for the Management of Refractory Non-Infectious Uveitis: A Proof-of-Concept Study Phase 4
Completed NCT03145025 - Corneal Endothelial Cell Density in Eyes Treated With a Fluocinolone Acetonide Intravitreal Implant
Withdrawn NCT01905124 - Safety &Efficacy of CF101 to Subjects With Uveitis Phase 2
Completed NCT03598452 - High-dose Intravitreal Injection of Ganciclovir for the Treatment of CMVR in HIV-negative Patients N/A
Completed NCT02049476 - Study of the Effectiveness of Ozurdex for the Control of Uveitis Phase 4
Completed NCT00404612 - A Study of LX211 in Active Sight Threatening, Non-infectious Intermediate-, Anterior and Intermediate-, Posterior-, or Pan-Uveitis Phase 3
Completed NCT02952001 - MAGNOLIA: Extension Study of Patients With Non-infectious Uveitis Who Participated in CLS1001-301
Not yet recruiting NCT06431373 - A Study of Brepocitinib in Adults With Active, Non-Infectious, Non-Anterior Uveitis Phase 3
Completed NCT03097315 - Suprachoroidal Injection of CLS-TA in Patients With Non-infectious Uveitis Phase 3

External Links