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| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | November 26, 2007 | ||||||||
| Last Updated Date | December 5, 2007 | ||||||||
| Start Date ICMJE | March 2007 | ||||||||
| Primary Completion Date | |||||||||
| Current Primary Outcome Measures ICMJE |
Central retinal thickness [ Time Frame: 4, 8, 12, 24, 72, and 168 houres ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00563940 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
BCVA [ Time Frame: 4, 8, 12, 24, 72, and 168 hours ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Short-Term Effects of Intravitreal Bevacizumab and Trimacinolone in Patients With Diabetic Macular Edema | ||||||||
| Official Title ICMJE | Short-Term Effects of Intravitreal Bevacizumab and Trimacinolone in Patients With Diabetic Macular Edema | ||||||||
| Brief Summary | Diabetic macular edema is a common complication of ocular diabetes mellitus and can cause blindness. Hypoxygenation of the retina stimulates tissue mediators, especially different subtypes of vascular endothelial growth factor (VEGF). VEGF is responsible for proliferation, extension and increased permeability of the vessels. The aim of our study was to examine the short-term effect of intravitreal bevacizumab (Avastin® 1.25 mg in 0.05 ml) and triamcinolone on visual acuity and central retinal thickness in patients with clinically significant diabetic macular edema (CSME). |
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| Detailed Description | |||||||||
| Study Phase | |||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Case-Only, Prospective | ||||||||
| Condition ICMJE | Diabetic Macular Edema | ||||||||
| Intervention ICMJE | |||||||||
| Study Arms / Comparison Groups | |||||||||
| 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 | Active, not recruiting | ||||||||
| Estimated Enrollment ICMJE | 30 | ||||||||
| Estimated Completion Date | March 2008 | ||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 20 Years to 80 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | Switzerland | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00563940 | ||||||||
| Responsible Party | |||||||||
| Study ID Numbers ICMJE | AUG 044/07, KEK E: 29-03-07 | ||||||||
| Study Sponsor ICMJE | University Hospital Inselspital, Berne | ||||||||
| Collaborators ICMJE | University of Bern | ||||||||
| Investigators ICMJE |
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| Information Provided By | University Hospital Inselspital, Berne | ||||||||
| Verification Date | November 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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