Clinical trial NCT01229202: Use of Bevacizumab to Modulate the Outcomes of Trabeculectomy Surgery
Official title: Use of Vascular Endothelial Growth Factor Inhibitor, Bevacizumab to Modulate the Outcomes of Trabeculectomy Surgery
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Glaucoma
Keywords: trabeculectomy
glaucoma surgery
bevacizumab
Vascular Endothelial Growth Inhibitor
glaucoma
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
First posted: 2010-10-27
Enrollment: 0
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: post surgery IOP (Intra Ocular Pressure Measurement)
timeFrame: one year post surgery
Secondary outcomes:
measure: bleb appearance
timeFrame: one year post surgery
measure: number of bleb needlings
timeFrame: one year post surgery
measure: number of glaucoma medications at 12 months postoperatively
timeFrame: one year post surgery
measure: eye complications
timeFrame: one year post surgery
measure: systemic complications
timeFrame: one year post surgery
measure: need for another glaucoma surgery to control glaucoma
timeFrame: one year post surgery
measure: postoperative visual acuity at 12 months
timeFrame: 12 months post surgery
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: CDHA
state: Nova Scotia
Study officials:
affiliation: CDHA Halifax Nova Scotia Canada
name: Lesya Shuba, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: