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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief 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.

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:

  • Endothelial Rejection Rate [ Time Frame: 12 Months ]
  • Incidence of Ocular Adverse Events [ Time Frame: 12 months ]
    Incidence and severity of ocular adverse events during the study (based on ophthalmic examination and subject self-reporting).
  • Incidence of Systemic Adverse Events [ Time Frame: 12 Months ]
    Incidence and severity of systemic adverse events during the study (based on physical examination, subject self-reporting, and changes in vital sign).


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Time from Surgery to Any Rejection Episode [ Time Frame: 16, 26, and 52 weeks post-op ]
    Time from surgery to occurrence of any rejection episode (endothelial, epithelial, subepithelial)
  • Time from Surgery to Graft Failure [ Time Frame: 12 Months ]
    Time from surgery to overall graft failure (regardless of cause)
  • Incidence of Delayed Epithelial Healing [ Time Frame: 7 days post-op ]
  • Endothelial Cell Density [ Time Frame: 52 Weeks ]
    Endothelial Cell Density (Compared at Weeks 26 & 52)
  • Central Corneal Thickness [ Time Frame: 52 Weeks ]
    Central corneal thickness at Weeks 16, 26, and 52
  • Frequency of Primary Graft Failure [ Time Frame: 52 Weeks ]
  • Change in Corneal Neovascularization Metrics [ Time Frame: 52 weeks ]

    Corneal NV Metrics Neovascular Area (NA): measuring the area of the corneal vessels themselves

    Vessel Caliber (VC): measuring the mean diameter of the corneal vessels

    Invasion Area (IA): measuring the fraction of corneal area in which vessels are present



Original Secondary Outcome: Same as current

Information By: Massachusetts Eye and Ear Infirmary

Dates:
Date Received: November 22, 2013
Date Started: April 2014
Date Completion: September 2018
Last Updated: April 6, 2017
Last Verified: April 2017