Study Stopped
The primary efficacy endpoint was not met
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
1 other identifier
interventional
368
2 countries
30
Brief Summary
This was a pivotal trial to determine whether LX201 reduces the likelihood of a graft rejection episode following corneal transplantation in patients at high immunological risk for rejection.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Apr 2007
Typical duration for phase_3
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 12, 2007
CompletedFirst Posted
Study publicly available on registry
March 14, 2007
CompletedStudy Start
First participant enrolled
April 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2010
CompletedOctober 11, 2012
October 1, 2012
1.9 years
March 12, 2007
October 9, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
graft rejection or graft failure
52 weeks
Study Arms (3)
LX201 0.50 inch implant
EXPERIMENTALLX201 implant contained 30% cyclosporine A by weight and 0.50 inch in length
LX201 0.75 inch implant
EXPERIMENTALLX201 implant contained 30% cyclosporine A by weight and 0.75 inch by length
Placebo 0.75 inch implant
PLACEBO COMPARATORSilicone implant not containing cyclosporine A, 0.75 inch in length
Interventions
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.
The placebo was a silicone implant 0.75 inch in length. It contained no cyclosporine A
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (30)
Cornea Consultants of Arizona
Phoenix, Arizona, 85032, United States
Loma Linda University Health Care
Loma Linda, California, 92354, United States
USC Doheny Eye Institute
Los Angeles, California, 90033, United States
Bascom Palmer Eye Institute
Miami, Florida, 33136, United States
Emory Eye Center
Atlanta, Georgia, 30322, United States
University of Illinois at Chicago
Chicago, Illinois, 60612, United States
Price Vision Group
Indianapolis, Indiana, 46260, United States
The Eye Center at Union Memorial Hospital
Baltimore, Maryland, 21218, United States
Wilmer Eye Institute, Cornea Service
Baltimore, Maryland, 21287, United States
New England Eye Center
Boston, Massachusetts, 02111, United States
W.K. Kellogg Eye Center - University of Michigan
Ann Arbor, Michigan, 48105, United States
MN Eye Consultants, P.A.
Bloomington, Minnesota, 55431, United States
Tauber Eye Center
Kansas City, Missouri, 64111, United States
Ophthalmology Associates
St Louis, Missouri, 63141, United States
UMDNJ - New Jersey Medical School Institute of Ophthalmology and Visual Science
Newark, New Jersey, 07103, United States
New York Eye and Ear Infirmary
New York, New York, 10003, United States
Mount Sinai School of Medicine
New York, New York, 10029, United States
Ophthalmic Consultants of Long Island
Rockville Centre, New York, 11570, United States
Cornea Consultants of Albany
Slingerlands, New York, 12159, United States
Duke University Eye Center
Durham, North Carolina, 27705, United States
University Hospitals Case Medical Center
Cleveland, Ohio, 44106, United States
Cornea Associates of Texas
Dallas, Texas, 75231, United States
Virginia Eye Consultants
Norfolk, Virginia, 23502, United States
Eye Associates NW
Seattle, Washington, 98104, United States
Augenklinik, Universitat Erlangen-Nurnberg
Erlangen, 91054, Germany
Cornea Bank, Universitätsklinikum Essen
Essen, 45122, Germany
Klinik fuer Ophthalmologie Campus Kiel
Kiel, 24105, Germany
Ludwig Maximilians Universität
München, 80336, Germany
Augenklinik der Technischen Universität München
München, 81675, Germany
Augenklinik Wuerzburg
Würzburg, 97080, Germany
Related Publications (1)
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.
PMID: 24780407DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Eddy Anglade, MD
Chief Medical Officer, Lux Biosciences, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 12, 2007
First Posted
March 14, 2007
Study Start
April 1, 2007
Primary Completion
March 1, 2009
Study Completion
November 1, 2010
Last Updated
October 11, 2012
Record last verified: 2012-10