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Use of Bevacizumab to Modulate the Outcomes of Trabeculectomy Surgery

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.
 
ClinicalTrials.gov Identifier: NCT01229202
Recruitment Status : Unknown
Verified June 2011 by Nova Scotia Health Authority.
Recruitment status was:  Recruiting
First Posted : October 27, 2010
Last Update Posted : July 1, 2011
Sponsor:
Information provided by:
Nova Scotia Health Authority

Tracking Information
First Submitted Date  ICMJE October 25, 2010
First Posted Date  ICMJE October 27, 2010
Last Update Posted Date July 1, 2011
Study Start Date  ICMJE July 2008
Estimated Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 25, 2010)
post surgery IOP (Intra Ocular Pressure Measurement) [ Time Frame: one year post surgery ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 25, 2010)
  • bleb appearance [ Time Frame: one year post surgery ]
  • number of bleb needlings [ Time Frame: one year post surgery ]
  • number of glaucoma medications at 12 months postoperatively [ Time Frame: one year post surgery ]
  • eye complications [ Time Frame: one year post surgery ]
  • systemic complications [ Time Frame: one year post surgery ]
  • need for another glaucoma surgery to control glaucoma [ Time Frame: one year post surgery ]
  • postoperative visual acuity at 12 months [ Time Frame: 12 months post surgery ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Use of Bevacizumab to Modulate the Outcomes of Trabeculectomy Surgery
Official Title  ICMJE Use of Vascular Endothelial Growth Factor Inhibitor, Bevacizumab to Modulate the Outcomes of Trabeculectomy Surgery
Brief Summary

Vascular epithelial growth factor (VEGF) plays a critical role in vessel growth and wound healing. Bevacizumab, a non specific VEGF inhibitor, has been successfully used for the treatment of eye diseases associated with neovascularization. The purpose of this randomized study is 1) to investigate the effects of intraoperative subtenon injection of bevacizumab on the outcomes of trabeculectomy surgery. 2) to measure plasma and aqueous levels of VEGF and assess its association with the outcomes of trabeculectomy surgery. Trabeculectomy surgery, where a small drainage canal is created at the front of the eye, is the most common glaucoma surgery performed worldwide. The goal of the surgery is to control intraocular pressure. Failure of this procedure is most commonly caused by excessive scarring of the surgical site. If scarring occurs, the drainage canal can close. By adding Bevacizumab at the time of surgery, wound healing may be slowed and surgical failure prevented.

The results of this study will be helpful in the future development of new more effective and safe surgical techniques for treatment of glaucoma.

Patients who have given informed consent are randomized into two groups. One group receives standard of care for trabeculectomy surgery and the other group receives standard of care plus an injection of Bevacizumab at the surgery site. Both groups have a one time collection of ocular fluid and a blood sample taken from a vein in the arm. After surgery, patients are seen by their study doctor six times in the following year. At these visits measurements are taken of their visual acuity, eye pressure and blood pressure. The doctor does a clinical exam and at months six and twelve photographs of the patients' eye are taken.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Glaucoma
Intervention  ICMJE Drug: Bevacizumab
single bevacizumab subtenon injection of 1.25 mg. at end of trabeculectomy surgery
Other Name: Avastin
Study Arms  ICMJE
  • Active Comparator: standard of care
    standard of care for trabeculectomy surgery
    Intervention: Drug: Bevacizumab
  • Active Comparator: bevacizumab arm
    Intervention: Drug: Bevacizumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 25, 2010)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2012
Estimated Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • any type of glaucoma, except neovascular or inflammatory
  • patients requiring trabeculectomy or combined cataract surgery with trabeculectomy surgery

Exclusion Criteria:

  • younger than 30 years of age
  • previous ocular surgeries excepting cataract surgeries
  • patients who have had or present with intraocular inflammation
  • neovascular glaucoma
  • patients who are aphakic
  • diabetic retinopathy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01229202
Other Study ID Numbers  ICMJE CD-2007-331
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lesya Shuba MD FRCSC PhD, Capital District Health Authority, Halifax, Nova Scotia,Canada
Study Sponsor  ICMJE Nova Scotia Health Authority
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Lesya Shuba, MD PhD CDHA Halifax Nova Scotia Canada
PRS Account Nova Scotia Health Authority
Verification Date June 2011

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