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Treatment with Ranibizumab of the residual diabetic edema in patients with failed response to Bevacizumab.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with 3-5 consecutive Avastin injections | Experimental | These patients will receive 0.5 mg of intravitreal Ranibizumab monthly for 6 months. |
|
| Patients with 6 or more consecutive injections of Bevacizumab | Experimental | Patients will receive 0.5 mg of intravitreal Ranibizumab during the first 6 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| injection of 0.5 mg of Intravitreal Ranibizumab | Drug | Following the sterile technique, intravitreal injection of anti-VEGF is applied |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects with resolution of diabetic macular edema compared to baseline as determined by mean foveal thickness on Spectralis < 300 microns. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the main change in BCVA (best corrected visual acuity) score over time | They will evaluate the amount of patients gaining 3 or more letters and the amount of patients losing 3 or more letters. | 6-12 months |
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Inclusion Criteria:
Subjects will be eligible if the following criteria are met:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nauman Chaudhry, MD | New England Retina Associates | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New England Retina Associates | Norwich | Connecticut | 06360 | United States |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D004487 | Edema |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System 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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|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |