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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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.

Detailed Summary:

The purpose of this study is to test the effectiveness of a drug, bevacizumab (Avastin), in preventing blood vessels that often occur after a corneal transplantation which are considered at "high-risk" for rejection. In many cases these blood vessels lead to the graft rejection and eventual failure of the corneal transplant. It is hoped that this treatment will increase the chances of corneal graft survival.

The medication used in this study is called bevacizumab or Avastin (Genentech, Inc). It works by inhibiting the action of a molecule called vascular endothelial growth factor (VEGF). VEGF is a substance molecule that binds to certain cells to stimulate new blood vessel formation. When VEGF is bound to the drug, it cannot stimulate the formation and growth of new blood vessels. Growth of blood vessels into the cornea is a complication which can worsen the prognosis of your corneal transplant and put the transplant at a higher risk for rejection.


Sponsor: Reza Dana, MD

Current Primary Outcome: Number of Participants With Graft Failure at Week 39 and 52 [ Time Frame: 12 months ]

Time from surgery to overall graft failure (regardless of cause). Graft failure was monitored throughout the entire study, but only the time points at which graft failure occurred are reported below.


Original Primary Outcome: Endothelial Rejection Rate [ Time Frame: 12 months ]

Current Secondary Outcome: Endothelial Cell Density [ Time Frame: 52 Weeks ]

Endothelial Cell Density (Assessed at Weeks 26 & 52). Measure of the number of cells present within the endothelium that are responsible for providing the cornea with nourishment.


Original Secondary Outcome:

  • Time from surgery to the occurrence of any rejection episode or overall graft failure [ Time Frame: 16, 26, and 52 weeks ]
  • Endothelial density and central corneal thickness [ Time Frame: 16, 26, and 52 weeks ]
  • Corneal NV metrics [ Time Frame: 16, 26, and 52 weeks ]


Information By: Massachusetts Eye and Ear Infirmary

Dates:
Date Received: February 18, 2010
Date Started: December 2009
Date Completion:
Last Updated: May 8, 2017
Last Verified: May 2017