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Completed

NCT Number: NCT01310764

Trabeculectomy With Subconjunctival Bevacizumab Injection

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rassoul Akram hospital, eye research center

Tehran, Tehran Province, 14455-364, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

trabeculectomy

Procedure

Both groups underwent trabeculectomy ,but in active group bevacizumab was used and in sham group mitomycin c was used during the surgery.

Primary outcomes

  1. Intraocular pressure.

    Time frame: 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 outcomes

  1. Number of medications.

    Time frame: 7-12 months

    Number of pre and post operative medications were recorded and compared in each post operative visits.

Sponsors and collaborators

Lead sponsor

Rassoul Akram Hospital

Other

Registry information

Official study title

Efficacy and Safety of Trabeculectomy With Subconjunctival Bevacizumab Versus Trabeculectomy With Mitomycin C.

Important dates

Study start
2009
Primary completion
2009
Study completion
2010
First posted
Mar 8, 2011
Registry last updated
Mar 29, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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