Status:
TERMINATED
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
Lead Sponsor:
Lux Biosciences, Inc.
Conditions:
Corneal Diseases
Cornea Transplant
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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.
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,...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
368 Patients enrolled
Trial Details
Trial ID
NCT00447187
Start Date
April 1 2007
End Date
November 1 2010
Last Update
October 11 2012
Active Locations (30)
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1
Cornea Consultants of Arizona
Phoenix, Arizona, United States, 85032
2
Loma Linda University Health Care
Loma Linda, California, United States, 92354
3
USC Doheny Eye Institute
Los Angeles, California, United States, 90033
4
Bascom Palmer Eye Institute
Miami, Florida, United States, 33136