Use of Bevacizumab in Trabeculectomy Surgery

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Glaucoma Research Society of Canada
Information provided by (Responsible Party):
Dr. Catherine Birt, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT01166594
First received: July 19, 2010
Last updated: October 8, 2013
Last verified: October 2013
  Purpose

When a patient with glaucoma who has a pressure that is too high and causing damage to their vision, despite receiving the maximum amount of medication that can be tolerated, the decision is made to have glaucoma surgery. Trabeculectomy is the most common form of glaucoma surgery used to treat open angle glaucoma. During trabeculectomy, an opening is created in the eye and partially covered with a flap of tissue. This new opening allows fluid to drain out of the eye bypassing the clogged drainage channels that are malfunctioning in patients with glaucoma. Studies have found that trabeculectomy significantly reduces vision loss and lowers eye pressure.

However, many people need another trabeculectomy or other glaucoma surgery because the surgery may fail either early or much later because the body closes the drain created by the surgeon. The surgery is also less likely to work in patients with darker pigmentation, children who have congenital glaucoma, people with difficult to control glaucoma with new blood vessels growing on the iris, diabetes or persons with prior eye surgery. As a result, the investigators need to find ways to improve the longterm survival of trabeculectomy surgery in all patients.


Condition Intervention Phase
Glaucoma
Optic Neuropathy
Fibrosis
Drug: Bevacizumab
Drug: Control
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Use of Bevacizumab in Trabeculectomy Surgery. A Prospective, 2 Centre, Randomized, Controlled Trial

Resource links provided by NLM:


Further study details as provided by Sunnybrook Health Sciences Centre:

Primary Outcome Measures:
  • Intraocular pressure [ Time Frame: One year ] [ Designated as safety issue: Yes ]
    Intraocular pressure comparison between the two groups at one year following surgery. A window of ±14 days was allowed for the one-year visit


Secondary Outcome Measures:
  • Bleb appearance [ Time Frame: One year ] [ Designated as safety issue: No ]
    Bleb appearance will be formally graded according to the Indiana bleb- grading scheme at the one year time point. Ophthalmic photographs of the surgical site will be taken with patient consent. The photographs only include a small portion of the eye and the patient cannot be identified by them.

  • 5-Fluorouracil (5-FU) injections [ Time Frame: One year ] [ Designated as safety issue: No ]
    The number of 5-FU injections needed during the first post-operative year for additional would modulation will be compared between the two groups.


Estimated Enrollment: 60
Study Start Date: June 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bevacizumab
Tested Drug
Drug: Bevacizumab
Intrableb injection
Other Name: Avastin
Placebo Comparator: Control
Control - BSS
Drug: Control
intrableb BSS injection
Other Name: Saline

Detailed Description:

The usual treatment is to not have an injection of Bevacizumab on the third through fifth day after trabeculectomy surgery. Topical anaesthetic drops to numb the eye will be given, prior to being given the tested medicine. Once the eye has been anaesthetized, the medication will be injected into the potential space created during the glaucoma surgery, also called a bleb, using a standard small syringe. The patient will receive an injection of either 1.25mg (0.05ml) of Bevacizumab or Balanced Salt Solution (BSS) into the trabeculectomy bleb that had been created in the surgery. Participants will be randomly (by chance) placed in one of the 2 study groups. There will be a 50% chance of being placed in either group. There will be 60 people who will participate in this study at 2 centres throughout the Toronto region. The length of this study for participants is 12 months, and the entire study is expected to take about 18 months to complete.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age more than 18 years old
  • Patients with glaucoma that is inadequately controlled on maximal tolerated medical therapy and scheduled for trabeculectomy surgery (with/without combined cataract extraction)
  • Decision makers fluent in English
  • Decision makers able to understand and read consent form

Exclusion Criteria:

  • Patients with active intraocular inflammation/uveitis or neovascular glaucoma
  • History of previous trabeculectomy surgery or prior retinal detachment with scleral buckle placement in the surgical eye
  • Aphakia in surgical eye
  • Pregnant and nursing women
  • Unable to fulfill inclusion criteria
  • Refusal of consent
  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: NCT01166594

Locations
Canada, Ontario
Sunnybrook Hospital
Toronto, Ontario, Canada, M4N 3M5
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Glaucoma Research Society of Canada
Investigators
Principal Investigator: Catherine Birt, MD, FRCSC Sunnybrook Hospital
  More Information

No publications provided

Responsible Party: Dr. Catherine Birt, MD, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT01166594     History of Changes
Other Study ID Numbers: 136783
Study First Received: July 19, 2010
Last Updated: October 8, 2013
Health Authority: Canada: Health Canada

Keywords provided by Sunnybrook Health Sciences Centre:
Glaucoma
Elevated Intraocular Pressure (IOP)
Optic Neuropathy
Bleb Failure
Avastin (Bevacizumab)

Additional relevant MeSH terms:
Fibrosis
Glaucoma
Optic Nerve Diseases
Pathologic Processes
Ocular Hypertension
Eye Diseases
Cranial Nerve Diseases
Nervous System Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 23, 2014