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Trabeculectomy With Subconjunctival Bevacizumab Injection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01310764
Recruitment Status : Completed
First Posted : March 8, 2011
Last Update Posted : March 29, 2011
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Glaucoma Procedure: Trabeculectomy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Trabeculectomy With Subconjunctival Bevacizumab Versus Trabeculectomy With Mitomycin C.
Study Start Date : April 2009
Actual Primary Completion Date : November 2009
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arm Intervention/treatment
Sham Comparator: Mitomycin C
Those with trabeculectomy and intraoperative application of mitomycin C.
Procedure: Trabeculectomy
Both groups underwent trabeculectomy ,but in active group bevacizumab was used and in sham group mitomycin c was used during the surgery.

Active Comparator: Bevacizumab
Those with trabeculectomy and adjunctive intraoperative subconjunctival injection of bevacizumab.
Procedure: Trabeculectomy
Both groups underwent trabeculectomy ,but in active group bevacizumab was used and in sham group mitomycin c was used during the surgery.

Primary Outcome Measures :
  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 Outcome Measures :
  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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01310764

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Iran, Islamic Republic of
Rassoul Akram hospital, eye research center
Tehran, Iran, Islamic Republic of, 14455-364
Sponsors and Collaborators
Rassoul Akram Hospital
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Responsible Party: Naveed Nilforushan, Rassoul Akram Hospital,Ophthalmic Research Center,Department of Ophthalmology,Iran University of Medical Sciences Identifier: NCT01310764    
Other Study ID Numbers: 971
First Posted: March 8, 2011    Key Record Dates
Last Update Posted: March 29, 2011
Last Verified: April 2009
Keywords provided by Rassoul Akram Hospital:
Intraocular pressure
Mitomycin C
Additional relevant MeSH terms:
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Ocular Hypertension
Eye Diseases