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| ID | Type | Description | Link |
|---|---|---|---|
| EY1313DE | Other Identifier | Company internal |
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| Name | Class |
|---|---|
| Regeneron Pharmaceuticals | INDUSTRY |
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The study aims to investigate the effectiveness of Eylea in patients with wet age-related macular degeneration in routine clinical practice in Germany. The study is purely observational, only data from routine treatment are to be collected. The treatment and treatment conditions are solely at discretion of the treating physician.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321) | Drug | Patients will be followed-up for 24 months |
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| Measure | Description | Time Frame |
|---|---|---|
| Mean change of visual acuity for the total patient population | Baseline, 12 and 24 months | |
| Mean change of visual acuity for the subgroup of pretreated patients | Baseline, 12 and 24 months | |
| Mean change of visual acuity for the subgroup of non-pretreated patients | Baseline, 12 and 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Monitoring of disease activity | Monitoring of disease activity in routine clinical practice setting will be assessed e.g. by determining the o No. of clinical visits (visits for injections) o No. of monitoring visits (visits only for diagnostic purposes, but without injections) o No. of safety visits after the injection (visits only for safety checks after injection) o No. of visits outside the study center o No. of OCT (optical coherence tomography) assessments per patient after 12 and 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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The study population will consist of patients with wAMD treated with Eylea. Participants will be recruited from ophthalmological clinics and practices throughout Germany.
The decision upon treatment is made at the discretion of the attending physician, according to his/her medical practice.
The medication is prescribed at regular visits to the investigator's office. Commercially available product will be used to treat the patients.
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Multiple Locations | Germany |
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| ID | Term |
|---|---|
| C533178 | aflibercept |
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| after 12 and 24 months |
| Monitoring of treatment patterns | same assessment as indicated for "Monitoring of disease activity" | after 12 and 24 months |
| Mean time from indication of Eylea-treatment by the treating physician to start of treatment | after 12 and 24 months |