Safety and Efficacy of Bevacizumab in High-Risk Corneal Transplant Survival

• Status: Completed
• Trial end date: 2015-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The leading risk factor for corneal transplant rejection is abnormal blood vessel growth of the host bed. Vascular endothelial growth factor (VEGF) is thought to be a mediator of this corneal neovascularization (NV), therefore we would like to test the safety and efficacy of local VEGF blockade in the promotion of graft survival in high risk corneal transplants.

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

Details

• Lead Sponsor: Massachusetts Eye and Ear Infirmary; Reza Dana, MD
• Treatments: Bevacizumab; Carboxymethylcellulose Sodium

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