Use of Bevacizumab to Modulate the Outcomes of Trabeculectomy Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Capital District Health Authority, Canada.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Capital District Health Authority, Canada
ClinicalTrials.gov Identifier:
NCT01229202
First received: October 25, 2010
Last updated: June 29, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention Phase
Glaucoma
Drug: Bevacizumab
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Use of Vascular Endothelial Growth Factor Inhibitor, Bevacizumab to Modulate the Outcomes of Trabeculectomy Surgery

Resource links provided by NLM:


Further study details as provided by Capital District Health Authority, Canada:

Primary Outcome Measures:
  • post surgery IOP (Intra Ocular Pressure Measurement) [ Time Frame: one year post surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • bleb appearance [ Time Frame: one year post surgery ] [ Designated as safety issue: No ]
  • number of bleb needlings [ Time Frame: one year post surgery ] [ Designated as safety issue: No ]
  • number of glaucoma medications at 12 months postoperatively [ Time Frame: one year post surgery ] [ Designated as safety issue: No ]
  • eye complications [ Time Frame: one year post surgery ] [ Designated as safety issue: Yes ]
  • systemic complications [ Time Frame: one year post surgery ] [ Designated as safety issue: Yes ]
  • need for another glaucoma surgery to control glaucoma [ Time Frame: one year post surgery ] [ Designated as safety issue: No ]
  • postoperative visual acuity at 12 months [ Time Frame: 12 months post surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: July 2008
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Avastin
Active Comparator: bevacizumab arm Drug: Bevacizumab
single bevacizumab subtenon injection of 1.25 mg. at end of trabeculectomy surgery
Other Name: Avastin

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01229202

Contacts
Contact: Lesya Shuba, MD, PhD 902 473-3410 lshuba@dal.ca
Contact: Mimi Stanfield, BA 901 473-3236 stanfieldmj@dal.ca

Locations
Canada, Nova Scotia
CDHA Recruiting
Halifax, Nova Scotia, Canada, B3H 2Y9
Sponsors and Collaborators
Capital District Health Authority, Canada
Investigators
Principal Investigator: Lesya Shuba, MD PhD CDHA Halifax Nova Scotia Canada
  More Information

No publications provided

Responsible Party: Lesya Shuba MD FRCSC PhD, Capital District Health Authority, Halifax, Nova Scotia,Canada
ClinicalTrials.gov Identifier: NCT01229202     History of Changes
Other Study ID Numbers: CD-2007-331
Study First Received: October 25, 2010
Last Updated: June 29, 2011
Health Authority: Capital District Health Ethics Board Halifax Nova Scotia Canada':'

Keywords provided by Capital District Health Authority, Canada:
trabeculectomy
glaucoma surgery
bevacizumab
Vascular Endothelial Growth Inhibitor
glaucoma

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases
Endothelial Growth Factors
Tumor Necrosis Factor Ligand Superfamily Member 15
Bevacizumab
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 22, 2014