- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00447187
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
A Multi-center, Placebo-Controlled, Randomized, Parallel Group, Dose-Ranging Study to Assess the Efficacy and Safety of LX201 for Prevention of Corneal Allograft Rejection Episodes and Graft Failure Following Penetrating Keratoplasty With LX201 Implantation in Subjects Who Are at Increased Immunological Risk
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
LX201 was a novel sustained-release silicone implant containing 30% cyclosporine A by weight. LX201 was intended for surgical episcleral placement in the eye.
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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Erlangen, Germany, 91054
- Augenklinik, Universitat Erlangen-Nurnberg
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Essen, Germany, 45122
- Cornea Bank, Universitätsklinikum Essen
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Kiel, Germany, 24105
- Klinik fuer Ophthalmologie Campus Kiel
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Muenchen, Germany, 80336
- Ludwig Maximilians Universität
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München, Germany, 81675
- Augenklinik der Technischen Universität München
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Wuerzburg, Germany, 97080
- Augenklinik Wuerzburg
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Arizona
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Phoenix, Arizona, United States, 85032
- Cornea Consultants of Arizona
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California
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Loma Linda, California, United States, 92354
- Loma Linda University Health Care
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Los Angeles, California, United States, 90033
- USC Doheny Eye Institute
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Florida
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Miami, Florida, United States, 33136
- Bascom Palmer Eye Institute
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Georgia
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Atlanta, Georgia, United States, 30322
- Emory Eye Center
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Illinois
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Chicago, Illinois, United States, 60612
- University Of Illinois at Chicago
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Indiana
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Indianapolis, Indiana, United States, 46260
- Price Vision Group
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Maryland
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Baltimore, Maryland, United States, 21218
- The Eye Center at Union Memorial Hospital
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Baltimore, Maryland, United States, 21287
- Wilmer Eye Institute, Cornea Service
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Massachusetts
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Boston, Massachusetts, United States, 02111
- New England Eye Center
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Michigan
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Ann Arbor, Michigan, United States, 48105
- W.K. Kellogg Eye Center - University of Michigan
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Minnesota
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Bloomington, Minnesota, United States, 55431
- MN Eye Consultants, P.A.
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Missouri
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Kansas City, Missouri, United States, 64111
- Tauber Eye Center
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St. Louis, Missouri, United States, 63141
- Ophthalmology Associates
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New Jersey
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Newark, New Jersey, United States, 07103
- UMDNJ - New Jersey Medical School Institute of Ophthalmology and Visual Science
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New York
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New York, New York, United States, 10029
- Mount Sinai School of Medicine
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New York, New York, United States, 10003
- New York Eye and Ear Infirmary
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Rockville Center, New York, United States, 11570
- Ophthalmic Consultants of Long Island
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Slingerlands, New York, United States, 12159
- Cornea Consultants of Albany
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North Carolina
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Durham, North Carolina, United States, 27705
- Duke University Eye Center
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Ohio
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Cleveland, Ohio, United States, 44106
- University Hospitals Case Medical Center
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Texas
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Dallas, Texas, United States, 75231
- Cornea Associates of Texas
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Virginia
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Norfolk, Virginia, United States, 23502
- Virginia Eye Consultants
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Washington
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Seattle, Washington, United States, 98104
- Eye Associates NW
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Subjects are candidates for a corneal transplant and are at increased immunological risk for graft failure, as evidenced by one or more of the following:
- ≥ 1 quadrant deep corneal vascularization
- verifiable history of graft failure due to rejection
- position of graft is < 1 mm from the limbus
Exclusion Criteria:
- Any condition that would greatly increase the risk of non-rejection graft failure such as Stevens-Johnson syndrome, xerophthalmia or severe exposure keratitis.
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: LX201 0.50 inch implant
LX201 implant contained 30% cyclosporine A by weight and 0.50 inch in length
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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. |
Experimental: LX201 0.75 inch implant
LX201 implant contained 30% cyclosporine A by weight and 0.75 inch by length
|
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 Comparator: Placebo 0.75 inch implant
Silicone implant not containing cyclosporine A, 0.75 inch in length
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The placebo was a silicone implant 0.75 inch in length.
It contained no cyclosporine A
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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graft rejection or graft failure
Time Frame: 52 weeks
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52 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Eddy Anglade, MD, Chief Medical Officer, Lux Biosciences, Inc.
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LX201-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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