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The aim of this integrated analysis is to describe the effectiveness of Eylea in an integrated pooled analysis using existing individual patient data of two non-interventional studies RAINBOW and PERSEUS.
The primary objective of this integrated analysis is to describe the effectiveness of Eylea on the mean change from baseline in visual acuity (VA) at 12 months in Wet age-related macular degeneration (wAMD) treatment naïve patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment naïve wAMD | Treatment naïve patients with wAMD treated with IVT aflibercept from the two underlying studies PERSEUS and RAINBOW |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321) | Drug | Patients observed with regular and irregular treatment course |
|
| Measure | Description | Time Frame |
|---|---|---|
| Absolute difference in visual acuity (VA) change from baseline will be calculated for each patient as: VA letter score at month 12 - VA letter score at baseline | At baseline and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mean time from diagnosis by the treating physician to start of treatment | At baseline | |
| Proportion of patients gaining 5, 10 or 15 or more letters | At 12 months | |
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Inclusion Criteria:
PERSEUS
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This integrated analysis will include only treatment naïve patients with wAMD treated with IVT aflibercept from the two underlying studies PERSEUS and RAINBOW.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Many locations | Multiple Locations | Germany |
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| Proportion of patients with ≥70 letters VA |
| At 12 months |
| Proportion of patients with ≥73 letters VA | At 12 months |
| Proportion of patients losing 5, 10 or 15 or more letters | At 12 months |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C533178 | aflibercept |
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