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| Name | Class |
|---|---|
| Glaucoma Research Society of Canada | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bevacizumab | Experimental | Tested Drug |
|
| Control | Placebo Comparator | Control - BSS |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bevacizumab | Drug | Intrableb injection |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | One year |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Catherine Birt, MD, FRCSC | Sunnybrook Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sunnybrook Hospital | Toronto | Ontario | M4N 3M5 | Canada |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bevacizumab | Tested Drug Bevacizumab: Intrableb injection - 30 patients |
| FG001 | Control | Control - BSS Control: intrableb BSS injection - 29 patients |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Bevacizumab | Tested Drug Bevacizumab: Intrableb injection |
| BG001 | Control | Control - BSS Control: intrableb BSS injection |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Mean | Standard Deviation | mm Hg | One year |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bevacizumab | Tested Drug Bevacizumab: Intrableb injection - 30 patients | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bleb leak | Eye disorders |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Other | Eye disorders | Other Adverse events included suprachoroidal hemorrhage, corneal abrasion, hyphema |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Catherine Birt | Sunnybrook Health Sciences Centre | 416 480-5882 | catherine.birt@sunnybrook.ca |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009901 | Optic Nerve Diseases |
| D005355 | Fibrosis |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Control | Drug | intrableb BSS injection |
|
|
| One year |
| 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. | One year |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
|
| 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. | Posted | Count of Participants | Participants | One year |
|
|
|
| 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. | Posted | Count of Participants | Participants | One year |
|
|
|
| 23 |
| 14 |
| 23 |
| 6 |
| 23 |
| EG001 | Control | Control - BSS Control: intrableb BSS injection - 29 patients | 0 | 24 | 11 | 24 | 7 | 24 |
| Hypotony | Eye disorders |
|
| Choroidal Detachment | Eye disorders |
|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |