Trabeculectomy With Subconjunctival Bevacizumab Injection

Not Applicable

Completed

• Conditions: Glaucoma
• Interventions: Procedure: Trabeculectomy

• Registration Number: NCT01310764
• Lead Sponsor: Rassoul Akram Hospital

Brief Summary

The purpose of this study is to investigate the safety and efficacy of bevacizumab as an adjunctive treatment to trabeculectomy in open angle glaucoma patients and to compare this new drug to the most commonly used anti-scarring agent, mitomycin C.

Detailed Description

The most common surgical technique for controlling the intraocular pressure in glaucoma patients is trabeculectomy.In this surgery, internal cavity of the eye is connected by a fistula like openings to subconjunctival space. The main cause of failure in trabeculectomy is excessive postoperative conjunctival scarring at the site of fistula, which is related to severity of conjunctival vascularization, tortuousity of vessel, and fibroblast migration and proliferation. At the time of surgery most surgeons use mitomycin C, which is an antimitotic and antifibrotic agent, to improve the results of the procedure. Although this agent is very effective, but is not without complication. The most significant and sight threatening complications are low intraocular pressure and endophthalmitis. Therefore investigations are going on to find a much safer and effective agents. Bevacizumab is a monoclonal antibody against vascular endothelial factor (VEGF). VEGF is an important vasculogenic and fibrogenic factor with a prominent role in wound healing.Bevacizumab is widely used in ophthalmology and has a promising effect in treatment of neovascularization in conjunctiva, cornea and retina. There are limited animal and human case series regarding the effect of this agent in trabeculectomy. In this study the investigators are trying, in addition to evaluating the efficacy and safety of this agent in result of trabeculectomy, compare this agent with mitomycin C.

Study Timeline

• Status Verified: 2009-04
• Study Start: 2009-04
• Primary Completion: 2009-11
• Study Completion: 2010-07
• Study First Submitted: 2011-03-07
• Study First Submitted QC: 2011-03-07
• Study First Posted: 2011-03-08
• Last Update Submitted: 2011-03-28
• Last Update Posted: 2011-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• Uncontrolled Open angle glaucoma.
• Glaucoma patients who are non-compliant to medical treatment.
• Progressive glaucoma despite of medical treatment.
• Follow-up of at least 6 months after surgery

Exclusion Criteria

• History of prior ocular surgery.
• Pregnancy or breast feeding.
• Age < 18 years.
• History of ocular surface infection in recent two weeks.
• History of systemic thrombo-embolic events.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mitomycin C	Trabeculectomy	Those with trabeculectomy and intraoperative application of mitomycin C.
Bevacizumab	Trabeculectomy	Those with trabeculectomy and adjunctive intraoperative subconjunctival injection of bevacizumab.

Primary Outcome Measures

Name	Time	Method
Intraocular pressure.	7-12 months	Pre and post operative intraocular pressures are measured with Goldmann applanation tonometer at each time point visits and the measurement were compared between both groups.

Secondary Outcome Measures

Name	Time	Method
Number of medications.	7-12 months	Number of pre and post operative medications were recorded and compared in each post operative visits.

Trial Locations

Locations (1)

Rassoul Akram hospital, eye research center; 🇮🇷 Tehran, Iran, Islamic Republic of