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Use of Bevacizumab to Modulate the Outcomes of Trabeculectomy Surgery

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

Status
Withdrawn
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01229202
Enrollment
0
Registered
2010-10-27
Start date
2008-07-31
Completion date
2016-01-31
Last updated
2024-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glaucoma

Keywords

trabeculectomy, glaucoma surgery, bevacizumab, Vascular Endothelial Growth Inhibitor, glaucoma

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.

Interventions

DRUGBevacizumab

single bevacizumab subtenon injection of 1.25 mg. at end of trabeculectomy surgery

Sponsors

Nova Scotia Health Authority
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
post surgery IOP (Intra Ocular Pressure Measurement)one year post surgery

Secondary

MeasureTime frame
number of bleb needlingsone year post surgery
number of glaucoma medications at 12 months postoperativelyone year post surgery
eye complicationsone year post surgery
bleb appearanceone year post surgery
need for another glaucoma surgery to control glaucomaone year post surgery
postoperative visual acuity at 12 months12 months post surgery
systemic complicationsone year post surgery

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026