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The purpose of this study is to evaluate the effects of panretinal photocoagulation plus intravitreal ranibizumab for the treatment of patients with high risk proliferative diabetic retinopathy in terms of changes in visual acuity and neovascularization area.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRP plus ranibizumab | Experimental | Patients will be submitted to panretinal photocoagulation plus intravitreal injections of ranibizumab |
|
| PRP | Active Comparator | Patients will only be submitted to panretinal photocoagulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ranibizumab | Drug | Ranibizumab (Lucentis), intravitreal injections of 0.05ml |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fluorescein leakage area (mm2) | Neovascularization area measured during fluorescein agiography middle phase | Week 48 after inclusion in the study |
| Measure | Description | Time Frame |
|---|---|---|
| CMT | Macular thickness measured with Stratus OCT protocols | Week 48 after inclusion in the study |
| LogMAR BCVA | LogMAR best corrected visual acuity measured with ETDRS charts |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of São Paulo | Ribeirão Preto | São Paulo | 14048-900 | Brazil |
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| Label | URL |
|---|---|
| article on Pubmed | View source |
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| ID | Term |
|---|---|
| D003930 | Diabetic Retinopathy |
| D015861 | Retinal Neovascularization |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000069579 | Ranibizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Panretinal Photocoagulation | Procedure | Panretinal photocoagulation with green laser according to ETDRS |
|
| Week 48 after inclusion in the study |
| Retina mid periphery visual field sensitivity change | Week 48 after inclusion in the study |
| Rod pathway integrity and oscillatory potential amplitudes | Week 48 after inclusion in the study |
| D002318 |
| Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D009389 | Neovascularization, Pathologic |
| D008679 | Metaplasia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |