The Effect of Bevacizumab on the Trabeculectomy

Phase 2

• Conditions: Glaucoma
• Interventions: Drug: intraocular injections of bevacizumab

• Registration Number: NCT01122966
• Lead Sponsor: Samsung Medical Center

Brief Summary

The investigators plan to evaluate the additive effect of intracameral and subconjunctival injections of bevacizumab in trabeculectomies with other antimetabolites.

Detailed Description

Glaucoma filtration surgery is routinely utilized to control intraocular pressure in glaucomatous patients. It reduces IOP by creating a fistula between the anterior chamber and the subconjunctival space with a filtering bleb. Increased wound healing response affects the function and morphology of the filtering bleb, and wound healing involves a series of biological events beginning with hemostasis.

Corticosteroids and antifibrosis agents such as mitomycin C and 5-fluorouracil have been employed in trabeculectomy to delay wound healing and hence to improve the success rate of surgery by inhibiting inflammation and fibroblastic activity, and the use of these antiscarring agents is generally believed to improve the success rate of trabeculectomy.But this rate decreased with passing time and thus was not perfect.

Vascular endothelial growth factor is a pivotal stimulator of angiogenesis because its binding to VEGF receptors has been demonstrated to promote endothelial cell migration and proliferation in wound healing.Therefore, anti-VEGF agents may potentially modulate wound healing following glaucoma filtration surgery.

The principal objective of this study was to evaluate the additive effect of intracameral and subconjunctival injections of bevacizumab in trabeculectomy.

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-04-15
• Status Verified: 2010-05
• Study First Submitted QC: 2010-05-12
• Study First Posted: 2010-05-13
• Last Update Submitted: 2010-05-25
• Last Update Posted: 2010-05-26
• Primary Completion: 2011-03
• Study Completion: 2012-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• glaucoma patients who have trabeculectomy

Exclusion Criteria

• patients with the other ocular disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
trabeculectomy	intraocular injections of bevacizumab	Subjects who have trabeculectomies with intraocular bevacizumab injection

Primary Outcome Measures

Name	Time	Method
intraocular pressure	on postoperative 1month	Intraocular pressure is planned to measure when the patient visit the clinic. All intraocular pressure measurements is acquired by glaucoma specialists, using a slitlamp-mounted Goldmann applanation tonometer.

Secondary Outcome Measures

Name	Time	Method
intraocular pressure	on postoperative 6months, 12months, 18months, 24months	Intraocular pressure is planned to measure when the patient visit the clinic. All intraocular pressure measurements is acquired by glaucoma specialists, using a slitlamp-mounted Goldmann applanation tonometer.

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of