Use of Bevacizumab in Trabeculectomy Surgery
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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 |
- 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.
| Estimated Enrollment: | 60 |
| 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) |
| 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 |
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| Canada, Ontario | |
| Sunnybrook Hospital | |
| Toronto, Ontario, Canada, M4N 3M5 | |
| 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: | December 13, 2012 |
| 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 June 18, 2013