A Multi-Center Study of the Safety and Efficacy of Bevacizumab in High-Risk Corneal Transplant Survival

• Status: Completed
• Trial end date: 2019-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The goal of this study is to investigate whether using bevacizumab (Avastin®) is both safe and effective at decreasing the likelihood of a high-risk corneal graft rejection. Patients who are "high-risk" for rejection have blood vessels growing from the white of the eye into the cornea (clear, front region of the eye). The medication is used at the time of surgery and in the weeks following surgery. Participants have a 50/50 chance at receiving the active study medication or a placebo medication.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts Eye and Ear Infirmary; Reza Dana, MD
• Collaborators: Bascom Palmer Eye Institute; New York Presbyterian Hospital; United States Department of Defense
• Treatments: Bevacizumab; Carboxymethylcellulose Sodium

Criteria

Inclusion Criteria:

• Age > 18 years

• Participant 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:

1. Presence of 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