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Trabeculectomy With Subconjunctival Bevacizumab Injection
This study has been completed.
Sponsor:
Rassoul Akram Hospital
Information provided by:
Rassoul Akram Hospital
ClinicalTrials.gov Identifier:
NCT01310764
First received: March 7, 2011
Last updated: March 28, 2011
Last verified: April 2009
| Tracking Information | |||
|---|---|---|---|
| First Received Date ICMJE | March 7, 2011 | ||
| Last Updated Date | March 28, 2011 | ||
| Start Date ICMJE | April 2009 | ||
| Primary Completion Date | November 2009 (Final data collection date for primary outcome measure) | ||
| Current Primary Outcome Measures ICMJE |
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. |
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| 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 |
Number of medications. [ Time Frame: 7-12 months ] Number of pre and post operative medications were recorded and compared in each post operative visits. |
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| 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 Provided | ||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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| 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. |
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| Study Arms |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||
| Recruitment Status ICMJE | Completed | ||
| Enrollment ICMJE | 36 | ||
| Completion Date | July 2010 | ||
| Primary Completion Date | November 2009 (Final data collection date for primary outcome measure) | ||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| 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 | ||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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