Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

March 7, 2011
March 28, 2011
April 2009
November 2009   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01310764 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Trabeculectomy With Subconjunctival Bevacizumab Injection
Efficacy and Safety of Trabeculectomy With Subconjunctival Bevacizumab Versus Trabeculectomy With Mitomycin C.

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Glaucoma
Procedure: Trabeculectomy
Both groups underwent trabeculectomy ,but in active group bevacizumab was used and in sham group mitomycin c was used during the surgery.
  • Sham Comparator: Mitomycin C
    Those with trabeculectomy and intraoperative application of mitomycin C.
    Intervention: Procedure: Trabeculectomy
  • Active Comparator: Bevacizumab
    Those with trabeculectomy and adjunctive intraoperative subconjunctival injection of bevacizumab.
    Intervention: Procedure: Trabeculectomy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
July 2010
November 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Iran, Islamic Republic of
 
NCT01310764
971
Yes
Naveed Nilforushan, Rassoul Akram Hospital,Ophthalmic Research Center,Department of Ophthalmology,Iran University of Medical Sciences
Rassoul Akram Hospital
Not Provided
Not Provided
Rassoul Akram Hospital
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP