Use of Bevacizumab in Trabeculectomy Surgery

Use of Bevacizumab in Trabeculectomy Surgery. A Prospective, 2 Centre, Randomized, Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Fibrosis; Glaucoma; Optic Neuropathy
• Intervention / Treatment: Drug: Bevacizumab; Drug: Control

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.

• Study Type: Interventional
• Enrollment (Actual): 59
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bevacizumab; Tested Drug	Drug: Bevacizumab; Intrableb injection; Other Names: Avastin
Placebo Comparator: Control; Control - BSS	Drug: Control; intrableb BSS injection; Other Names: Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraocular Pressure	Intraocular pressure comparison between the two groups at one year following surgery. A window of ±14 days was allowed for the one-year visit	One year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improved Bleb Appearance	Improved bleb appearance was formally graded according to the Indiana bleb-grading scheme at each visit. The scheme has 4 sections: height of the bleb (H) with a range of H0 (flat bleb) to H4 (high bleb), horizontal extent of the bleb with a range of E0 (less than 1 clock hour) to E3 (more than 4 clock hours), vascularity of the bleb with a range of V0 (avascular) to V4 (extensive vascularity), and siedel test ranging from S0 (no leak) to S2 (streaming leak within 5 seconds). Each section was individually scored. Ophthalmic photographs of the surgical site were taken with patient consent. The photographs only included a small portion of the eye and the patient cannot be identified by them.	One year
The Number of Participants Who Received 5-Fluorouracil (5-FU) Injections	The number of participants who needed 5-FU injections during the first post-operative year for additional would modulation will be compared between the two groups.	One year

Collaborators and Investigators

• Sponsor: Sunnybrook Health Sciences Centre
• Collaborators: Glaucoma Research Society of Canada
• Investigators: Principal Investigator: Catherine Birt, MD, FRCSC, Sunnybrook Hospital

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Actual): September 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: July 19, 2010
• First Submitted That Met QC Criteria: July 20, 2010
• First Posted (Estimated): July 21, 2010

Study Record Updates

• Last Update Posted (Actual): August 21, 2023
• Last Update Submitted That Met QC Criteria: October 28, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Optic Neuropathy; Glaucoma; Elevated Intraocular Pressure (IOP); Bleb Failure; Avastin (Bevacizumab)
• Additional Relevant MeSH Terms: Nervous System Diseases; Eye Diseases; Ocular Hypertension; Cranial Nerve Diseases; Glaucoma; Optic Nerve Diseases; Physiological Effects of Drugs; Antineoplastic Agents; Antineoplastic Agents, Immunological; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Bevacizumab
• Other Study ID Numbers: 136783