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| Name | Class |
|---|---|
| Fundação de Amparo à Pesquisa do Estado de São Paulo | OTHER_GOV |
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The purpose of this study is to compare the morphological and visual acuity outcomes associated with 1.5 mg bevacizumab versus 0.5 ranibizumab intravitreal injections for treatment of diabetic macular edema.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bevacizumab | Experimental | Treatment of macular edema with intravitreal Bevacizumab |
|
| Ranibizumab | Experimental | Treatment of macular edema with intravitreal Ranibizumab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab, 1.5 mg, intravitreal, throughout the study |
|
| Measure | Description | Time Frame |
|---|---|---|
| Central subfield macular thickness (CSFT) change | Central subfield macular thickness (CSFT) measured with spectral-domain optical coherence tomography (OCT) | Monthly from baseline to Week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Best-corrected visual acuity change | Best-corrected visual acuity using ETDRS charts | Monthly from baseline to week 48 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rodrigo Jorge, MD, PhD | University of Sao Paulo | Principal Investigator |
| Felipe Almeida, MD | Hospital das Clinicas - Faculdade de Medicina de Ribeirão Preto | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinics Hospital of Ribeirão Preto, School of Medicine of Ribeirão Preto, USP | Ribeirão Preto | São Paulo | 14048-900 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23795985 | Derived | Nepomuceno AB, Takaki E, Paes de Almeida FP, Peroni R, Cardillo JA, Siqueira RC, Scott IU, Messias A, Jorge R. A prospective randomized trial of intravitreal bevacizumab versus ranibizumab for the management of diabetic macular edema. Am J Ophthalmol. 2013 Sep;156(3):502-510.e2. doi: 10.1016/j.ajo.2013.04.026. Epub 2013 Jun 21. |
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| ID | Term |
|---|---|
| D003930 | Diabetic Retinopathy |
| D008269 | Macular Edema |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| D000069579 | Ranibizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Ranibizumab | Drug | Ranibizumab, 0.5 mg, intravitreal, throughout the study |
|
|
| D002318 |
| Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |