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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Corneal Diseases, Cornea Transplant

In brief

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.

Key facts

Study ID

NCT00447187

Run by

Lux Biosciences, Inc.

People needed

368

Starts

2007-04-01

Expected to finish

2010-11-01

Last updated by the study team

2012-10-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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