Trabeculectomy With Subconjunctival Bevacizumab Injection

Tracking Information
First Submitted Date ICMJE	March 7, 2011
First Posted Date ICMJE	March 8, 2011
Last Update Posted Date	March 29, 2011
Study Start Date ICMJE	April 2009
Actual Primary Completion Date	November 2009 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: March 7, 2011)	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.
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01310764 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: March 7, 2011)	Number of medications. [ Time Frame: 7-12 months ]; Number of pre and post operative medications were recorded and compared in each post operative visits.
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Trabeculectomy With Subconjunctival Bevacizumab Injection
Official Title ICMJE	Efficacy and Safety of Trabeculectomy With Subconjunctival Bevacizumab Versus Trabeculectomy With Mitomycin C.
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.
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.
Study Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Glaucoma
Intervention ICMJE	Procedure: Trabeculectomy; Both groups underwent trabeculectomy ,but in active group bevacizumab was used and in sham group mitomycin c was used during the surgery.
Study Arms	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
Publications *	Grewal DS, Jain R, Kumar H, Grewal SP. Evaluation of subconjunctival bevacizumab as an adjunct to trabeculectomy a pilot study. Ophthalmology. 2008 Dec;115(12):2141-2145.e2. doi: 10.1016/j.ophtha.2008.06.009. Epub 2008 Aug 9.; Memarzadeh F, Varma R, Lin LT, Parikh JG, Dustin L, Alcaraz A, Eliott D. Postoperative use of bevacizumab as an antifibrotic agent in glaucoma filtration surgery in the rabbit. Invest Ophthalmol Vis Sci. 2009 Jul;50(7):3233-7. doi: 10.1167/iovs.08-2441. Epub 2009 Jan 31.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: March 7, 2011)	36
Original Actual Enrollment ICMJE	Same as current
Actual Study Completion Date	July 2010
Actual Primary Completion Date	November 2009 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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.
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 75 Years (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Iran, Islamic Republic of
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01310764
Other Study ID Numbers ICMJE	971
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Naveed Nilforushan, Rassoul Akram Hospital,Ophthalmic Research Center,Department of Ophthalmology,Iran University of Medical Sciences
Study Sponsor ICMJE	Rassoul Akram Hospital
Collaborators ICMJE	Not Provided
Investigators ICMJE	Not Provided
PRS Account	Rassoul Akram Hospital
Verification Date	April 2009
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP