Study to Assess the Efficacy and Safety of LX201 for Prevention of Corneal Allograft Rejection Episodes and Graft Failure in Subjects at Increased Immunological Risk
NCT ID: NCT00447187
Last Updated: 2012-10-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
368 participants
INTERVENTIONAL
2007-04-30
2010-11-30
Brief Summary
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Detailed Description
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The study was a Phase 2/3, multi-center, placebo-controlled, randomized, parallel-group, dose-ranging study of LX201 for prevention of corneal allograft rejection or graft failure following penetrating keratoplasty with LX201 implantation. Subjects were to be followed in an outpatient setting for safety and efficacy at 4-6 week intervals for 52 weeks following transplantation surgery.
After Visit 12 (Week 52), subjects in the USA and India with the implant in the study eye were to be followed for safety at least once per year for a 2-year period or until time of implant removal. For subjects in the USA and India, if the implant was removed at any time prior to the 3 year safety follow-up, the subject was to have a final safety follow up visit at 3 months post removal. In Germany, the implant was to be removed at Week 52 with a 3-month safety follow-up period after removal.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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LX201 0.50 inch implant
LX201 implant contained 30% cyclosporine A by weight and 0.50 inch in length
LX201
LX201 is a novel sustained-release silicone implant containing 30% cyclosporine A by weight.
LX201 was available in two different lengths, 0.50 and 0.75 inch. Each implant was 0.08 inch wide and 0.04 inch in height. The implants were flat on one side (the posterior surface, which is applied to the episclera) and the anterior surface and ends were rounded.
LX201 0.75 inch implant
LX201 implant contained 30% cyclosporine A by weight and 0.75 inch by length
LX201
LX201 is a novel sustained-release silicone implant containing 30% cyclosporine A by weight.
LX201 was available in two different lengths, 0.50 and 0.75 inch. Each implant was 0.08 inch wide and 0.04 inch in height. The implants were flat on one side (the posterior surface, which is applied to the episclera) and the anterior surface and ends were rounded.
Placebo 0.75 inch implant
Silicone implant not containing cyclosporine A, 0.75 inch in length
Placebo
The placebo was a silicone implant 0.75 inch in length. It contained no cyclosporine A
Interventions
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LX201
LX201 is a novel sustained-release silicone implant containing 30% cyclosporine A by weight.
LX201 was available in two different lengths, 0.50 and 0.75 inch. Each implant was 0.08 inch wide and 0.04 inch in height. The implants were flat on one side (the posterior surface, which is applied to the episclera) and the anterior surface and ends were rounded.
Placebo
The placebo was a silicone implant 0.75 inch in length. It contained no cyclosporine A
Eligibility Criteria
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Inclusion Criteria
* ≥ 1 quadrant deep corneal vascularization
* verifiable history of graft failure due to rejection
* position of graft is \< 1 mm from the limbus
Exclusion Criteria
* Schirmer's test ≤ 5 mm in 1 minute
* Clinical evidence of limbal stem cell deficiency
* History of or active herpes simplex virus keratitis or other acute corneal infection
* Subjects who have had \> 3 failed grafts in the study eye
* Uncontrolled glaucoma as evidenced by an intraocular pressure of \>21 mmHg while on maximal medical therapy
* Clinically suspected or confirmed ocular lymphoma
* Treatment with a systemic immunosuppressive regimen within the previous 30 days; systemic prednisone (or its equivalent) of ≤ 10 mg daily is, however, permitted.
* Any implantable corticosteroid-eluting device (e.g., Retisert™, Posurdex®, Medidur™, I-vation™ TA intravitreal implant)
* Subjects who periodically require high-dose systemic steroid treatment (e.g., for exacerbation of chronic obstructive pulmonary disease).
* Subjects who have received treatment with a monoclonal antibody or any other biologic therapy within the previous 90 days or alemtuzumab within the previous 12 months
* History of herpes zoster or varicella infection within 6 weeks prior to enrollment, or chicken pox exposure within 21 days before enrollment
* Seropositivity for human immunodeficiency virus (HIV)
* Previous exposure or known contraindication to administration of cyclosporine
* Recipients of a solid organ transplant
* Currently pregnant or lactating
* Active, extraocular and/or systemic infection requiring the prolonged or chronic use of antimicrobial agents or the presence of active hepatitis A, B or C
* Severe anemia (hemoglobin \< 6 g/dL), leukopenia (white blood cell count \[WBC\] \< 2500 mm3), thrombocytopenia (platelet count \< 80,000 mm3), polycythemia (hematocrit \[Hct\] \> 54% \[male\] or Hct \> 49% \[female\]) or clinically significant coagulopathy
* Current malignancy or a history of malignancy (within the previous 5 years) except non-metastatic basal or squamous cell carcinoma of the skin or carcinoma-in-situ of the cervix that has been treated successfully
* Active peptic ulcer disease
* Co-morbid conditions that require immunosuppression
18 Years
ALL
No
Sponsors
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Lux Biosciences, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Eddy Anglade, MD
Role: STUDY_CHAIR
Chief Medical Officer, Lux Biosciences, Inc.
Locations
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Cornea Consultants of Arizona
Phoenix, Arizona, United States
Loma Linda University Health Care
Loma Linda, California, United States
USC Doheny Eye Institute
Los Angeles, California, United States
Bascom Palmer Eye Institute
Miami, Florida, United States
Emory Eye Center
Atlanta, Georgia, United States
University of Illinois at Chicago
Chicago, Illinois, United States
Price Vision Group
Indianapolis, Indiana, United States
The Eye Center at Union Memorial Hospital
Baltimore, Maryland, United States
Wilmer Eye Institute, Cornea Service
Baltimore, Maryland, United States
New England Eye Center
Boston, Massachusetts, United States
W.K. Kellogg Eye Center - University of Michigan
Ann Arbor, Michigan, United States
MN Eye Consultants, P.A.
Bloomington, Minnesota, United States
Tauber Eye Center
Kansas City, Missouri, United States
Ophthalmology Associates
St Louis, Missouri, United States
UMDNJ - New Jersey Medical School Institute of Ophthalmology and Visual Science
Newark, New Jersey, United States
New York Eye and Ear Infirmary
New York, New York, United States
Mount Sinai School of Medicine
New York, New York, United States
Ophthalmic Consultants of Long Island
Rockville Centre, New York, United States
Cornea Consultants of Albany
Slingerlands, New York, United States
Duke University Eye Center
Durham, North Carolina, United States
University Hospitals Case Medical Center
Cleveland, Ohio, United States
Cornea Associates of Texas
Dallas, Texas, United States
Virginia Eye Consultants
Norfolk, Virginia, United States
Eye Associates NW
Seattle, Washington, United States
Augenklinik, Universitat Erlangen-Nurnberg
Erlangen, , Germany
Cornea Bank, Universitätsklinikum Essen
Essen, , Germany
Klinik fuer Ophthalmologie Campus Kiel
Kiel, , Germany
Ludwig Maximilians Universität
München, , Germany
Augenklinik der Technischen Universität München
München, , Germany
Augenklinik Wuerzburg
Würzburg, , Germany
Countries
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References
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Bock F, Matthaei M, Reinhard T, Bohringer D, Christoph J, Ganslandt T, Cursiefen C. High-dose subconjunctival cyclosporine a implants do not affect corneal neovascularization after high-risk keratoplasty. Ophthalmology. 2014 Sep;121(9):1677-82. doi: 10.1016/j.ophtha.2014.03.016. Epub 2014 Apr 26.
Related Links
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Related Info
Other Identifiers
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LX201-01
Identifier Type: -
Identifier Source: org_study_id