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| ID | Type | Description | Link |
|---|---|---|---|
| NN1201 | Other Identifier | Company internal |
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| Name | Class |
|---|---|
| Regeneron Pharmaceuticals | INDUSTRY |
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POLARIS : A non-interventional study in patients with diabetic macular edema (DME) with central involvement to assess the effectiveness of existing anti-vascular endothelial growth factor (anti-VEGF) treatment regimens.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group1 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ranibizumab (or other DME treatment) | Drug | Patients with DME having started treatment with an approved anti-VEGF therapy at or after 01 October 2012 and then continuing with this or any kind or no treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in visual acuity, assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) or SNELLEN | Baseline, after 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Demographic and clinical characteristics (Age, sex, race, employment status, severity of DME) | Baseline | |
| Mean time from diagnosis to first commencement with an approved anti-VEGF therapy | Date of first diagnosis; Date of treatment initiation: up to 24 month |
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Inclusion Criteria:
Exclusion Criteria:
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In- and outpatients at participating sites with a diagnosis of DME with central involvement. Patients will be enrolled after the decision for treatment with an approved anti-VEGF therapy has been made at or after October 2012 by the study physician.
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Many Locations | France | |||||
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| Changes in retinal thickness, measured by Optical Coherence Tomography (OCT) | Baseline, after 12 month |
| Presence of clinically significant macular edema, measured as defined by the ETDRS Research Group | Baseline, after each month, up to 12 month |
| Resource utilization in terms of treatment choices, frequency and duration | Baseline, after 6 and 12 months |
| Mean change in quality of life score (using the NEI VFQ 25), only in countries where used as part of routine practice | Baseline, after 6 and 12 months |
| Many Locations |
| Germany |
| Many Locations | Greece |
| Many Locations | Portugal |
| Many Locations | Russia |
| Many Locations | Slovakia |
| Many Locations | Spain |
| Many Locations | United Kingdom |
| ID | Term |
|---|---|
| D008269 | Macular Edema |
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| 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 |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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