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| Name | Class |
|---|---|
| Regeneron Pharmaceuticals | INDUSTRY |
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The study will assess the mean change in Visual Acuity (VA) (overall and stratified by baseline VA) at year 1 and 2 of treatment with Aflibercept in real-life setting.
In addition, the study will ascertain the baseline VA in treatment -naïve Wet Age-Related Macular Degeneration or neo-vascular AMD (wAMD) patients who start treatment with Aflibercept in a real-life setting and it will assess the impact of baseline VA on the outcomes of Aflibercept treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| >= 70 letters | Baseline VA >= 70 letters |
| |
| 36-69 letters | Baseline VA 36-69 letters |
| |
| <=35 letters | Baseline VA <=35 letters |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aflibercept (Eylea, BAY86-5321) | Drug | Treatment-naïve eyes with neovascularization AMD (Age-related Macular Degeneration), with the indication to be treated with Aflibercept. One and/or two eyes per patient. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Visual Acuity (VA) (Snellen) | Change in VA (Snellen) at 3±1 months, 6±1months, 12±2 months and at 24±2 months follow-up in all eyes and stratified in the three groups by Visual Acuity (VA) at baseline. | at 3±1 months, 6±1months, 12±2 months and at 24±2 months follow-up |
| Change in Early Treatment Diabetic Retinopathy Study (ETDRS) | Change Early Treatment Diabetic Retinopathy Study (ETDRS) in all eyes and stratified in the three groups by VA at baseline. | at 3±1 months, 6±1months, 12±2 months and at 24±2 months follow-up |
| Change in Lasbarhetsindex (LIX, Readability Index) | Change in LIX in all eyes and stratified in the three groups by VA at baseline. LIX: Jaeger/LIX adult A chart (Ortho-KM, Lund, Sweden). The LIX-chart is a standardized readability index for measuring near vision and it is used almost ubiquitously in eye clinics in Sweden | at 3±1 months, 6±1months, 12±2 months and at 24±2 months follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with Gain of vision 5 to 15 letters; > 15 letters; Loss of vision >5 to <15 letters; >15 letters or Stable -5 to +5 letters at the annual time points | Patients with Gain of vision 5-15 letters, > 15 letters; Loss of vision >5-<15 letters; >15 letters or Stable -5-+5 letters at the annual time points | At year 1 and year 2 |
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Inclusion Criteria:
Exclusion Criteria:
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All patients registered in the Swedish Macula Register during the study period.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Many locations | Lund | Sweden |
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| ID | Term |
|---|---|
| D057135 | Wet Macular Degeneration |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C533178 | aflibercept |
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| Proportion of patients that recuperate 20/20 vision (driving vision) in all patients and stratified by baseline VA (groups 1-3) | In all patients and stratified by baseline VA (groups 1-3) | Up to 2 years |
| Proportion of patients that recuperate 20/40 vision (driving vision) in all patients and stratified by baseline VA (groups 1-3) | In all patients and stratified by baseline VA (groups 1-3) | Up to 2 years |
| Proportion of patients with no need of Vision Aid support | Up to 2 years |