Trabeculectomy With Subconjunctival Bevacizumab Injection

This study has been completed.
Sponsor:
Information provided by:
Rassoul Akram Hospital
ClinicalTrials.gov Identifier:
NCT01310764
First received: March 7, 2011
Last updated: March 28, 2011
Last verified: April 2009
  Purpose

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 Intervention
Glaucoma
Procedure: Trabeculectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Trabeculectomy With Subconjunctival Bevacizumab Versus Trabeculectomy With Mitomycin C.

Resource links provided by NLM:


Further study details as provided by Rassoul Akram Hospital:

Primary Outcome Measures:
  • Intraocular pressure. [ Time Frame: 7-12 months ] [ Designated as safety issue: No ]
    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:
  • Number of medications. [ Time Frame: 7-12 months ] [ Designated as safety issue: No ]
    Number of pre and post operative medications were recorded and compared in each post operative visits.


Enrollment: 36
Study Start Date: April 2009
Study Completion Date: July 2010
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01310764

Locations
Iran, Islamic Republic of
Rassoul Akram hospital, eye research center
Tehran, Iran, Islamic Republic of, 14455-364
Sponsors and Collaborators
Rassoul Akram Hospital
  More Information

Publications:
Responsible Party: Naveed Nilforushan, Rassoul Akram Hospital,Ophthalmic Research Center,Department of Ophthalmology,Iran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01310764     History of Changes
Other Study ID Numbers: 971
Study First Received: March 7, 2011
Last Updated: March 28, 2011
Health Authority: Iran: Ethics Committee

Keywords provided by Rassoul Akram Hospital:
Intraocular pressure
Trabeculectomy
Mitomycin C
Bevacizumab

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases
Mitomycins
Mitomycin
Bevacizumab
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Alkylating Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on July 22, 2014