Use of Bevacizumab to Modulate the Outcomes of Trabeculectomy Surgery

NCT ID: NCT01229202

Last Updated: 2024-08-21

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2016-01-31

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.

Conditions

Glaucoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

standard of care

standard of care for trabeculectomy surgery

Group Type: ACTIVE_COMPARATOR

Bevacizumab

Intervention Type: DRUG

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

bevacizumab arm

Group Type: ACTIVE_COMPARATOR

Bevacizumab

Intervention Type: DRUG

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

Interventions

Bevacizumab

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

Intervention Type: DRUG

Other Intervention Names

Avastin

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

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nova Scotia Health Authority

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lesya Shuba, MD PhD

Role: PRINCIPAL_INVESTIGATOR

CDHA Halifax Nova Scotia Canada

Locations

CDHA

Halifax, Nova Scotia, Canada

Countries

Canada

Other Identifiers

CD-2007-331

Identifier Type: -

Identifier Source: org_study_id