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

This is an interventional prevention trial for Corneal Diseases focused on measuring corneal graft failure, corneal graft rejection, corneal transplant rejection Read More

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