Use of Bevacizumab in Trabeculectomy Surgery

NCT ID: NCT01166594

Last Updated: 2023-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2013-12-31

Brief Summary

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.

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.

Conditions

Glaucoma; Optic Neuropathy; Fibrosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Bevacizumab

Tested Drug

Group Type: EXPERIMENTAL

Bevacizumab

Intervention Type: DRUG

Intrableb injection

Control

Control - BSS

Group Type: PLACEBO_COMPARATOR

Control

Intervention Type: DRUG

intrableb BSS injection

Interventions

Bevacizumab

Intrableb injection

Intervention Type: DRUG

Control

intrableb BSS injection

Intervention Type: DRUG

Other Intervention Names

Avastin; Saline

Eligibility 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

• Refusal of consent

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Glaucoma Research Society of Canada

OTHER

Sponsor Role: collaborator

Sunnybrook Health Sciences Centre

OTHER

Sponsor Role: lead

Responsible Party

Dr. Catherine Birt

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Catherine Birt, MD, FRCSC

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook Hospital

Locations

Sunnybrook Hospital

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

136783

Identifier Type: -

Identifier Source: org_study_id