Use of Bevacizumab to Modulate the Outcomes of Trabeculectomy Surgery

Glaucoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01229202
• Other study ID #: CD-2007-331
• Status: Recruiting
• Phase: Phase 4
• First received: October 25, 2010
• Last updated: June 29, 2011
• Start date: July 2008
• Est. completion date: June 2012

Study information

• Verified date: June 2011
• Source: Nova Scotia Health Authority
• Contact: Lesya Shuba, MD, PhD
• Phone: 902 473-3410
• Email: lshuba[@]dal.ca
• Is FDA regulated: No
• Health authority: Capital District Health Ethics Board Halifax Nova Scotia Canada':'
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Glaucoma

Intervention

Drug:
• Bevacizumab
single bevacizumab subtenon injection of 1.25 mg. at end of trabeculectomy surgery

Locations

Country	Name	City	State
Canada	CDHA	Halifax	Nova Scotia

Sponsors (1)

Lead Sponsor	Collaborator
Nova Scotia Health Authority

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	post surgery IOP (Intra Ocular Pressure Measurement)		one year post surgery	No
Secondary	bleb appearance		one year post surgery	No
Secondary	number of bleb needlings		one year post surgery	No
Secondary	number of glaucoma medications at 12 months postoperatively		one year post surgery	No
Secondary	eye complications		one year post surgery	Yes
Secondary	systemic complications		one year post surgery	Yes
Secondary	need for another glaucoma surgery to control glaucoma		one year post surgery	No
Secondary	postoperative visual acuity at 12 months		12 months post surgery	No