Use of Bevacizumab to Modulate the Outcomes of Trabeculectomy Surgery

Nova Scotia Health Authority (NSHA)

Status and phase: Withdrawn; Phase 4

Conditions: Glaucoma

Treatments: Drug: Bevacizumab

Study type: Interventional

Funder types: Other

Identifiers

NCT01229202

CD-2007-331

Details and patient eligibility

About

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.

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

standard of care

Active Comparator group

Description:

standard of care for trabeculectomy surgery

Treatment:

Drug: Bevacizumab

bevacizumab arm

Active Comparator group

Treatment:

Drug: Bevacizumab