Use of Bevacizumab to Modulate the Outcomes of Trabeculectomy Surgery

Phase 4

Withdrawn

• Conditions: Glaucoma
• Interventions: Drug: Bevacizumab

• Registration Number: NCT01229202
• Lead Sponsor: Nova Scotia Health Authority

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2010-10-25
• Study First Submitted QC: 2010-10-25
• Study First Posted: 2010-10-27
• Primary Completion: 2012-12
• Study Completion: 2016-01
• Status Verified: 2022-10
• Last Update Submitted: 2024-08-19
• Last Update Posted: 2024-08-21

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
standard of care	Bevacizumab	standard of care for trabeculectomy surgery
bevacizumab arm	Bevacizumab	-

Primary Outcome Measures

Name	Time	Method
post surgery IOP (Intra Ocular Pressure Measurement)	one year post surgery

Secondary Outcome Measures

Name	Time	Method
postoperative visual acuity at 12 months	12 months post surgery
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
systemic complications	one year post surgery
need for another glaucoma surgery to control glaucoma	one year post surgery
eye complications	one year post surgery

Trial Locations

Locations (1)

CDHA; 🇨🇦 Halifax, Nova Scotia, Canada