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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01072357
First Posted: February 22, 2010
Last Update Posted: May 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Reza Dana, MD, Massachusetts Eye and Ear Infirmary
February 18, 2010
February 22, 2010
March 27, 2017
May 15, 2017
May 15, 2017
December 2009
January 2015   (Final data collection date for primary outcome measure)
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.
Endothelial Rejection Rate [ Time Frame: 12 months ]
Complete list of historical versions of study NCT01072357 on ClinicalTrials.gov Archive Site
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.
  • 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 ]
Not Provided
Not Provided
 
Safety and Efficacy of Bevacizumab in High-Risk Corneal Transplant Survival
Safety and Efficacy of Bevacizumab in High-Risk Corneal Transplant Survival
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.

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
  • Corneal Neovascularization
  • Corneal Graft Failure
  • Drug: Avastin® (bevacizumab)
    One time subconjunctival injection of 0.1 mL (2.5 mg) bevacizumab followed by topical treatment with 1% solution bevacizumab four times a day for four weeks.
    Other Names:
    • Avastin
    • bevacizumab
  • Drug: 0.9% NaCl & Refresh Liquigel
    One-time subconjunctival injection of 0.1mL 0.9% NaCl followed by topical treatment with Refresh Liquigel four times a day for four weeks
    Other Names:
    • Sodium Chloride
    • Refresh Liquigel
    • NaCL
  • Active Comparator: Avastin® (bevacizumab)

    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.

    Intervention: Drug: Avastin® (bevacizumab)
  • Placebo Comparator: 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 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.

    Intervention: Drug: 0.9% NaCl & Refresh Liquigel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
January 2015
January 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01072357
09-07-062
Yes
Not Provided
Plan to Share IPD: No
Reza Dana, MD, Massachusetts Eye and Ear Infirmary
Reza Dana, MD
Not Provided
Principal Investigator: Reza Dana, MD, MPH, MSc Massachusetts Eye and Ear Infirmary
Massachusetts Eye and Ear Infirmary
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP