Trabeculectomy With Subconjunctival Bevacizumab Injection

Rassoul Akram Hospital

Status: Completed

Conditions: Glaucoma

Treatments: Procedure: Trabeculectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT01310764

971

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

Mitomycin C

Sham Comparator group

Description:

Those with trabeculectomy and intraoperative application of mitomycin C.

Treatment:

Procedure: Trabeculectomy

Bevacizumab

Active Comparator group

Description:

Those with trabeculectomy and adjunctive intraoperative subconjunctival injection of bevacizumab.

Treatment:

Procedure: Trabeculectomy