Use of Bevacizumab to Modulate the Outcomes of Trabeculectomy Surgery

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: Unknown
• Conditions: Glaucoma
• Intervention / Treatment: Drug: Bevacizumab

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Lesya Shuba, MD, PhD; Phone Number: 902 473-3410; Email: lshuba@dal.ca
• Study Contact Backup: Name: Mimi Stanfield, BA; Phone Number: 901 473-3236; Email: stanfieldmj@dal.ca

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

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)	one year post surgery

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Nova Scotia Health Authority
• Investigators: Principal Investigator: Lesya Shuba, MD PhD, CDHA Halifax Nova Scotia Canada

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (ANTICIPATED): December 1, 2011
• Study Completion (ANTICIPATED): June 1, 2012

Study Registration Dates

• First Submitted: October 25, 2010
• First Submitted That Met QC Criteria: October 25, 2010
• First Posted (ESTIMATE): October 27, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): July 1, 2011
• Last Update Submitted That Met QC Criteria: June 29, 2011
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Keywords: bevacizumab; glaucoma; trabeculectomy; glaucoma surgery; Vascular Endothelial Growth Inhibitor
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Physiological Effects of Drugs; Antineoplastic Agents; Antineoplastic Agents, Immunological; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Bevacizumab
• Other Study ID Numbers: CD-2007-331