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| Tracking Information | |||||
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| First Received Date ICMJE | September 4, 2007 | ||||
| Last Updated Date | September 4, 2007 | ||||
| Start Date ICMJE | January 2007 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
early post-vitrectomy vitreous hemorrhage | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
Visual improvement | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effect of Intravitreal Bevacizumab on Early Post-Vitrectomy Hemorrhage in Diabetic Patients | ||||
| Official Title ICMJE | |||||
| Brief Summary | The purpose of this study is to determine whether bevacizumab 1-2 weeks before vitrectomy is effective in lowering the rate of early post-vitrectomy vitreous hemorrhage in diabetic patients. |
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| Detailed Description | Diabetes is the leading cause of blindness in the age range of 20-64 years. Pars plana vitrectomy may be indicated for the management of advanced proliferative diabetic retinopathy. Early post-vitrectomy hemorrhage in diabetic patients is relatively common; it occurs in 29% -75% of patients in the first month after surgery. This may cause delayed visual rehabilitation and detection of surgical complications such as retinal break or detachment. Preliminary reports such as case series reported by Spaide RF, et al showed beneficial effect of bevacizumab in proliferative diabetic retinopathy complicated by vitreous hemorrhage. |
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| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study | ||||
| Condition ICMJE | Diabetic Retinopathy | ||||
| Intervention ICMJE | Drug: Bevacizumab | ||||
| Study Arms / Comparison Groups |
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| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 80 | ||||
| Estimated Completion Date | September 2007 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | |||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Iran, Islamic Republic of | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00524875 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | 8657 | ||||
| Study Sponsor ICMJE | Shaheed Beheshti Medical University | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Shaheed Beheshti Medical University | ||||
| Verification Date | August 2007 | ||||
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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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