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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-021182-76 | EudraCT Number |
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This study is designed to explore a more individualized treatment regime based on achievement of disease stability to define a personal optimal treatment interval with ranibizumab in patients with visual impairment due to diabetic macular edema.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ranibizumab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ranibizumab | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Best Corrected Visual Acuity(BCVA) | from month 0 (baseline) to month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| change in central retinal thickness (CRT) | from month 0 to month 12 | |
| the number of injections needed | 12 months | |
| the number of patients with improvement in BCVA from baseline |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Oslo | 0264 | Norway |
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| ID | Term |
|---|---|
| D008269 | Macular Edema |
| D003930 | Diabetic Retinopathy |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye 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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| 12 months |
| the number of patients with > 5, 10 and 15 letters improvement from baseline, the latter including patients reaching BCVA >84 | 12 months |
| D003925 |
| Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |