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| ID | Type | Description | Link |
|---|---|---|---|
| IBEViH |
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The purpose of this study is to determine the effect of pre and intra-operative bevacizumab injection on postoperative vitreous hemorrhage after diabetic vitrectomy in comparison to vitrectomy without bevacizumab injection.
Postoperative vitreous hemorrhage is a common complication after vitrectomy for proliferative diabetic retinopathy. Bevacizumab (Avastin) is a potent inhibitor of angiogenesis and has been shown to decrease retinal and iris neovascularization in proliferative diabetic retinopathy. We believe that preoperative bevacizumab injection could reduce postoperative vitreous hemorrhage by decreasing the amount of abnormal vessels and intraoperative injection could also reduce postoperative vitreous hemorrhage by inhibiting the vessel formation after surgery
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 - no bevacizumab | No Intervention | Patients will not receive bevacizumab before nor during vitrectomy | |
| 2- bevacizumab before vitrectomy | Experimental | Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) 7 days before vitrectomy |
|
| 3- bevacizumab after vitrectomy | Experimental | Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) at the end of vitrectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bevacizumab | Drug | 1.25 mg of bevacizumab (0.05 ml) 7 days before vitrectomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recurrent vitreous hemorrhage incidence after vitrectomy | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Visual outcome | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hospital das ClÃnicas de Ribeirão Preto - USP | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Felipe Almeida, MD | University of Sao Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital das ClÃnicas de Ribeirão Preto - University of São Paulo | Recruiting | Ribeirão Preto | São Paulo | 14049-990 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17995982 | Background | Tonello M, Costa RA, Almeida FP, Barbosa JC, Scott IU, Jorge R. Panretinal photocoagulation versus PRP plus intravitreal bevacizumab for high-risk proliferative diabetic retinopathy (IBeHi study). Acta Ophthalmol. 2008 Jun;86(4):385-9. doi: 10.1111/j.1600-0420.2007.01056.x. Epub 2007 Nov 7. | |
| 37260074 | Derived |
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| ID | Term |
|---|---|
| D014823 | Vitreous Hemorrhage |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D005130 | Eye Hemorrhage |
| D005128 | Eye Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| bevacizumab | Drug | 1.25 mg of bevacizumab (0.05 ml) at the end of vitrectomy |
|
| Dervenis P, Dervenis N, Smith JM, Steel DH. Anti-vascular endothelial growth factors in combination with vitrectomy for complications of proliferative diabetic retinopathy. Cochrane Database Syst Rev. 2023 May 31;5(5):CD008214. doi: 10.1002/14651858.CD008214.pub4. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |