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Use of Bevacizumab to Modulate the Outcomes of Trabeculectomy Surgery

Primary Purpose

Glaucoma

Status
Unknown status
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Bevacizumab
Sponsored by
Nova Scotia Health Authority
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Glaucoma focused on measuring trabeculectomy, glaucoma surgery, bevacizumab, Vascular Endothelial Growth Inhibitor, glaucoma

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CDHARecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

standard of care

bevacizumab arm

Arm Description

standard of care for trabeculectomy surgery

Outcomes

Primary Outcome Measures

post surgery IOP (Intra Ocular Pressure Measurement)

Secondary Outcome Measures

bleb appearance
number of bleb needlings
number of glaucoma medications at 12 months postoperatively
eye complications
systemic complications
need for another glaucoma surgery to control glaucoma
postoperative visual acuity at 12 months

Full Information

First Posted
October 25, 2010
Last Updated
June 29, 2011
Sponsor
Nova Scotia Health Authority
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1. Study Identification

Unique Protocol Identification Number
NCT01229202
Brief Title
Use of Bevacizumab to Modulate the Outcomes of Trabeculectomy Surgery
Official Title
Use of Vascular Endothelial Growth Factor Inhibitor, Bevacizumab to Modulate the Outcomes of Trabeculectomy Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Unknown status
Study Start Date
July 2008 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
June 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Nova Scotia Health Authority

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
Keywords
trabeculectomy, glaucoma surgery, bevacizumab, Vascular Endothelial Growth Inhibitor, glaucoma

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
standard of care
Arm Type
Active Comparator
Arm Description
standard of care for trabeculectomy surgery
Arm Title
bevacizumab arm
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Other Intervention Name(s)
Avastin
Intervention Description
single bevacizumab subtenon injection of 1.25 mg. at end of trabeculectomy surgery
Primary Outcome Measure Information:
Title
post surgery IOP (Intra Ocular Pressure Measurement)
Time Frame
one year post surgery
Secondary Outcome Measure Information:
Title
bleb appearance
Time Frame
one year post surgery
Title
number of bleb needlings
Time Frame
one year post surgery
Title
number of glaucoma medications at 12 months postoperatively
Time Frame
one year post surgery
Title
eye complications
Time Frame
one year post surgery
Title
systemic complications
Time Frame
one year post surgery
Title
need for another glaucoma surgery to control glaucoma
Time Frame
one year post surgery
Title
postoperative visual acuity at 12 months
Time Frame
12 months post surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lesya Shuba, MD, PhD
Phone
902 473-3410
Email
lshuba@dal.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Mimi Stanfield, BA
Phone
901 473-3236
Email
stanfieldmj@dal.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lesya Shuba, MD PhD
Organizational Affiliation
CDHA Halifax Nova Scotia Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
CDHA
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

Use of Bevacizumab to Modulate the Outcomes of Trabeculectomy Surgery

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