Fibrosis, Glaucoma, Optic Neuropathy
Conditions
Keywords
Glaucoma, Elevated Intraocular Pressure (IOP), Optic Neuropathy, Bleb Failure, Avastin (Bevacizumab)
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.
Interventions
DRUGBevacizumab
Intrableb injection
DRUGControl
intrableb BSS injection
Sponsors
Glaucoma Research Society of Canada
Sunnybrook Health Sciences Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Improved Bleb Appearance | One year | 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. |
| The Number of Participants Who Received 5-Fluorouracil (5-FU) Injections | One year | 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. |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bevacizumab Tested Drug
Bevacizumab: Intrableb injection | 23 |
| Control Control - BSS
Control: intrableb BSS injection | 24 |
| Total | 47 |
Baseline characteristics
| Characteristic | Bevacizumab | Control | Total |
|---|---|---|---|
| Age, Continuous | 63.7 years STANDARD_DEVIATION 10.8 | 61.3 years STANDARD_DEVIATION 10.4 | 62.5 years STANDARD_DEVIATION 10.6 |
| Region of Enrollment Canada | 23 participants | 24 participants | 47 participants |
| Sex: Female, Male Female | 14 Participants | 11 Participants | 25 Participants |
| Sex: Female, Male Male | 9 Participants | 13 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 23 | 0 / 24 |
| other Total, other adverse events | 6 / 23 | 7 / 24 |
| serious Total, serious adverse events | 14 / 23 | 11 / 24 |
Outcome results
Primary
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
Time frame: One year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bevacizumab | Intraocular Pressure | 13.9 mm Hg | Standard Deviation 4.5 |
| Control | Intraocular Pressure | 13.2 mm Hg | Standard Deviation 5.1 |
p-value: <0.05t-test, 2 sided
Secondary
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.
Time frame: One year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Bevacizumab | Improved Bleb Appearance | 14 Participants |
| Control | Improved Bleb Appearance | 12 Participants |
Secondary
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.
Time frame: One year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Bevacizumab | The Number of Participants Who Received 5-Fluorouracil (5-FU) Injections | 13 Participants |
| Control | The Number of Participants Who Received 5-Fluorouracil (5-FU) Injections | 7 Participants |