Use of Bevacizumab in Trabeculectomy Surgery

Sponsor

Sunnybrook Health Sciences Centre (Other)

Overall Status

Completed

CT.gov ID

NCT01166594

Collaborator

Glaucoma Research Society of Canada (Other)

Enrollment

Location

Arms

Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma Optic Neuropathy Fibrosis	Drug: Bevacizumab Drug: Control	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

47 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jun 1, 2010

Actual Primary Completion Date :

Sep 1, 2013

Actual Study Completion Date :

Dec 1, 2013

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Intraocular pressure [One year]
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 [One year]
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 [One year]
The number of 5-FU injections needed during the first post-operative year for additional would modulation will be compared between the two groups.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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