Use of Bevacizumab to Modulate the Outcomes of Trabeculectomy Surgery

Study Overview
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Brief Summary
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Vascular epithelial growth factor (VEGF) plays a critical role in vessel growth and wound healing. Bevacizumab, a non specific VEGF inhibitor, has been successfully used for the treatment of eye diseases associated with neovascularization. The purpose of this randomized study is 1) to investigate the effects of intraoperative subtenon injection of bevacizumab on the outcomes of trabeculectomy surgery. 2) to measure plasma and aqueous levels of VEGF and assess its association with the outcomes of trabeculectomy surgery. Trabeculectomy surgery, where a small drainage canal is created at the front of the eye, is the most common glaucoma surgery performed worldwide. The goal of the surgery is to control intraocular pressure. Failure of this procedure is most commonly caused by excessive scarring of the surgical site. If scarring occurs, the drainage canal can close. By adding Bevacizumab at the time of surgery, wound healing may be slowed and surgical failure prevented. The results of this study will be helpful in the future development of new more effective and safe surgical techniques for treatment of glaucoma. Patients who have given informed consent are randomized into two groups. One group receives standard of care for trabeculectomy surgery and the other group receives standard of care plus an injection of Bevacizumab at the surgery site. Both groups have a one time collection of ocular fluid and a blood sample taken from a vein in the arm. After surgery, patients are seen by their study doctor six times in the following year. At these visits measurements are taken of their visual acuity, eye pressure and blood pressure. The doctor does a clinical exam and at months six and twelve photographs of the patients' eye are taken.

Official Title
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Use of Vascular Endothelial Growth Factor Inhibitor, Bevacizumab to Modulate the Outcomes of Trabeculectomy Surgery

Conditions
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Glaucoma

Intervention / Treatment
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* Drug: Bevacizumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: any type of glaucoma, except neovascular or inflammatory patients requiring trabeculectomy or combined cataract surgery with trabeculectomy surgery Exclusion Criteria: younger than 30 years of age previous ocular surgeries excepting cataract surgeries patients who have had or present with intraocular inflammation neovascular glaucoma patients who are aphakic diabetic retinopathy

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: standard of care<br>standard of care for trabeculectomy surgery | Drug: Bevacizumab<br>* single bevacizumab subtenon injection of 1.25 mg. at end of trabeculectomy surgery<br>* Other names: Avastin;|
| Active Comparator: bevacizumab arm<br> | Drug: Bevacizumab<br>* single bevacizumab subtenon injection of 1.25 mg. at end of trabeculectomy surgery<br>* Other names: Avastin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| post surgery IOP (Intra Ocular Pressure Measurement) |  | one year post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bleb appearance |  | one year post surgery | 
| number of bleb needlings |  | one year post surgery | 
| number of glaucoma medications at 12 months postoperatively |  | one year post surgery | 
| eye complications |  | one year post surgery | 
| systemic complications |  | one year post surgery | 
| need for another glaucoma surgery to control glaucoma |  | one year post surgery | 
| postoperative visual acuity at 12 months |  | 12 months post surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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trabeculectomy, glaucoma surgery, bevacizumab, Vascular Endothelial Growth Inhibitor, glaucoma