NCT01229202

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2008

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

October 25, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 27, 2010

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

August 21, 2024

Status Verified

October 1, 2022

Enrollment Period

4.4 years

First QC Date

October 25, 2010

Last Update Submit

August 19, 2024

Conditions

Glaucoma

Keywords

trabeculectomyglaucoma surgerybevacizumabVascular Endothelial Growth Inhibitorglaucoma

Outcome Measures

Primary Outcomes (1)

  • post surgery IOP (Intra Ocular Pressure Measurement)

    one year post surgery

Secondary Outcomes (7)

  • bleb appearance

    one year post surgery

  • number of bleb needlings

    one year post surgery

  • number of glaucoma medications at 12 months postoperatively

    one year post surgery

  • eye complications

    one year post surgery

  • systemic complications

    one year post surgery

  • +2 more secondary outcomes

Study Arms (2)

standard of care

ACTIVE COMPARATOR

standard of care for trabeculectomy surgery

Drug: Bevacizumab

bevacizumab arm

ACTIVE COMPARATOR
Drug: Bevacizumab

Interventions

BevacizumabDRUG

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

Also known as: Avastin
bevacizumab armstandard of care

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • any type of glaucoma, except neovascular or inflammatory
  • patients requiring trabeculectomy or combined cataract surgery with trabeculectomy surgery

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CDHA

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

MeSH Terms

Conditions

Glaucoma

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Lesya Shuba, MD PhD

    CDHA Halifax Nova Scotia Canada

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2010

First Posted

October 27, 2010

Study Start

July 1, 2008

Primary Completion

December 1, 2012

Study Completion

January 1, 2016

Last Updated

August 21, 2024

Record last verified: 2022-10

Locations

CA(1)