Use of Bevacizumab to Modulate the Outcomes of Trabeculectomy Surgery

August 19, 2024 updated by: Nova Scotia Health Authority

Use of Vascular Endothelial Growth Factor Inhibitor, Bevacizumab to Modulate the Outcomes of Trabeculectomy Surgery

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • CDHA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: standard of care
standard of care for trabeculectomy surgery
Drug: Bevacizumab
single bevacizumab subtenon injection of 1.25 mg. at end of trabeculectomy surgery
Other Names:
  • Avastin
Active Comparator: bevacizumab arm
Drug: Bevacizumab
single bevacizumab subtenon injection of 1.25 mg. at end of trabeculectomy surgery
Other Names:
  • Avastin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
post surgery IOP (Intra Ocular Pressure Measurement)
Time Frame: one year post surgery
one year post surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
bleb appearance
Time Frame: one year post surgery
one year post surgery
number of bleb needlings
Time Frame: one year post surgery
one year post surgery
number of glaucoma medications at 12 months postoperatively
Time Frame: one year post surgery
one year post surgery
eye complications
Time Frame: one year post surgery
one year post surgery
systemic complications
Time Frame: one year post surgery
one year post surgery
need for another glaucoma surgery to control glaucoma
Time Frame: one year post surgery
one year post surgery
postoperative visual acuity at 12 months
Time Frame: 12 months post surgery
12 months post surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nova Scotia Health Authority

Investigators

  • Principal Investigator: Lesya Shuba, MD PhD, CDHA Halifax Nova Scotia Canada

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2008

Primary Completion (Estimated)

December 1, 2012

Study Completion (Estimated)

January 1, 2016

Study Registration Dates

First Submitted

October 25, 2010

First Submitted That Met QC Criteria

October 25, 2010

First Posted (Estimated)

October 27, 2010

Study Record Updates

Last Update Posted (Actual)

August 21, 2024

Last Update Submitted That Met QC Criteria

August 19, 2024

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CD-2007-331

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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