Use of Bevacizumab to Modulate the Outcomes of Trabeculectomy Surgery
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Glaucoma |
Drug: Bevacizumab |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | Use of Vascular Endothelial Growth Factor Inhibitor, Bevacizumab to Modulate the Outcomes of Trabeculectomy Surgery |
- post surgery IOP (Intra Ocular Pressure Measurement) [ Time Frame: one year post surgery ] [ Designated as safety issue: No ]
- bleb appearance [ Time Frame: one year post surgery ] [ Designated as safety issue: No ]
- number of bleb needlings [ Time Frame: one year post surgery ] [ Designated as safety issue: No ]
- number of glaucoma medications at 12 months postoperatively [ Time Frame: one year post surgery ] [ Designated as safety issue: No ]
- eye complications [ Time Frame: one year post surgery ] [ Designated as safety issue: Yes ]
- systemic complications [ Time Frame: one year post surgery ] [ Designated as safety issue: Yes ]
- need for another glaucoma surgery to control glaucoma [ Time Frame: one year post surgery ] [ Designated as safety issue: No ]
- postoperative visual acuity at 12 months [ Time Frame: 12 months post surgery ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 60 |
| Study Start Date: | July 2008 |
| Estimated Study Completion Date: | June 2012 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: standard of care
standard of care for trabeculectomy surgery
|
Drug: Bevacizumab
single bevacizumab subtenon injection of 1.25 mg. at end of trabeculectomy surgery
Other Name: Avastin
|
| Active Comparator: bevacizumab arm |
Drug: Bevacizumab
single bevacizumab subtenon injection of 1.25 mg. at end of trabeculectomy surgery
Other Name: Avastin
|
Eligibility| Ages Eligible for Study: | 30 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Lesya Shuba, MD, PhD | 902 473-3410 | lshuba@dal.ca |
| Contact: Mimi Stanfield, BA | 901 473-3236 | stanfieldmj@dal.ca |
| Canada, Nova Scotia | |
| CDHA | Recruiting |
| Halifax, Nova Scotia, Canada, B3H 2Y9 | |
| Principal Investigator: | Lesya Shuba, MD PhD | CDHA Halifax Nova Scotia Canada |
More Information
No publications provided
| Responsible Party: | Lesya Shuba MD FRCSC PhD, Capital District Health Authority, Halifax, Nova Scotia,Canada |
| ClinicalTrials.gov Identifier: | NCT01229202 History of Changes |
| Other Study ID Numbers: | CD-2007-331 |
| Study First Received: | October 25, 2010 |
| Last Updated: | June 29, 2011 |
| Health Authority: | Capital District Health Ethics Board Halifax Nova Scotia Canada':' |
Keywords provided by Capital District Health Authority, Canada:
|
trabeculectomy glaucoma surgery bevacizumab Vascular Endothelial Growth Inhibitor glaucoma |
Additional relevant MeSH terms:
|
Glaucoma Ocular Hypertension Eye Diseases Endothelial Growth Factors Tumor Necrosis Factor Ligand Superfamily Member 15 Bevacizumab Growth Substances |
Physiological Effects of Drugs Pharmacologic Actions Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Inhibitors Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013