Use of Bevacizumab in Trabeculectomy Surgery
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 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|
- 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
- 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.
|Study Start Date:||June 2010|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Other Name: Avastin
Placebo Comparator: Control
Control - BSS
intrableb BSS injection
Other Name: Saline
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.
|Toronto, Ontario, Canada, M4N 3M5|
|Principal Investigator:||Catherine Birt, MD, FRCSC||Sunnybrook Hospital|