Use of Bevacizumab to Modulate the Outcomes of Trabeculectomy Surgery
Status:
Unknown status
Trial end date:
2012-06-01
Target enrollment:
Participant gender:
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.