Safety and Efficacy of Bevacizumab in High-Risk Corneal Transplant Survival
Corneal Neovascularization, Corneal Graft Failure
About this trial
This is an interventional treatment trial for Corneal Neovascularization focused on measuring High-Risk Corneal Transplantation, Penetrating Keratoplasty, Neovascularization, Corneal Blood Vessels, Avastin, Bevacizumab, Corneal Graft
Eligibility Criteria
Inclusion Criteria:
- Age > 18 years
- Patient or legally authorized representative willing and able to provide written informed consent
- Willing and able to comply with study assessments for the full duration of the study
- High-risk characteristics for penetrating keratoplasty: Either presence of 1.) Corneal NV in one or more quadrants (≥ 3 clock hours NV ≥ 2mm from the limbus) OR 2.) Extension of corneal NV to graft-host junction in a previous failed graft
- In generally good stable overall health
Exclusion Criteria:
- History of Stevens-Johnson syndrome or ocular pemphigoid
- Ocular or periocular malignancy
- Non-healing epithelial defect of at least 0.5x0.5 mm in host corneal bed lasting ≥6 weeks preoperatively
- Uncontrolled glaucoma
- Currently on dialysis
- Has received treatment with anti-VEGF agents (intraocular or systemic) within 45 days of study entry
- Concurrent use of systemic anti-VEGF agents
- Change in topical corticosteroid regimen within 14 days of transplantation
- Use of systemic immunosuppressive for indication other than corneal graft rejection
- Pregnancy (positive pregnancy test) or lactating
- Pre-menopausal women not using adequate contraception (Reliable intrauterine devices, hormonal contraception or a spermicide in combination with a barrier method)
- Uncontrolled hypertension defined as systolic blood pressure (BP) ≥150 or diastolic BP ≥90 mmHg
- History of thromboembolic event within 12 months prior to study entry
- Participation in another simultaneous medical investigation or trial
Sites / Locations
- Massachusetts Eye and Ear Infirmary
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Avastin® (bevacizumab)
0.9% NaCl & Refresh Liquigel
Treatment will begin on Day 0, immediately upon the conclusion of the penetrating keratoplasty procedure with an injection of 0.1 milliliter (mL) (2.5 mg) bevacizumab. Starting Day 1 post-transplant surgery, subjects will begin treatment with topical bevacizumab (1% solution). Topical treatment will be self-administered 4 times a day for 4 weeks. The study treatments are to be given in addition to standard of care treatments. Also, all patients will follow a standard post-operative follow-up visit schedule.
Treatment will begin on Day 0, immediately upon the conclusion of the penetrating keratoplasty procedure with an injection of 0.1 mL 0.9% sodium chloride (NaCl). Starting Day 1 post-transplant surgery, subjects will begin treatment with topical Refresh Liquigel. Topical treatment will be self-administered 4 times a day for 4 weeks. The study treatments (both topical and subconjunctival injection) are to be given in addition to standard of care treatments. Also, all patients will follow a standard post-operative follow-up visit schedule.