The Impact of Baseline Visual Acuity on the Treatment Outcomes in Patients Treated With AflIbercept in Real-life Clinical Setting

Study Overview
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Brief Summary
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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.

Official Title
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INSIGHT - The Impact of baseliNe viSual Acuity on the Treatment Outcomes in Patients Treated With AflIbercept in Real-life Clinical settinG. Analysis of Data From the SwedisH Macula RegisTer

Conditions
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Wet Macular Degeneration

Intervention / Treatment
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* Drug: Aflibercept (Eylea, BAY86-5321)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Treatment-naïve eyes with neovascularization AMD, with the indication to be treated with Aflibercept. One and/or two eyes per patient. Exclusion Criteria: Eyes treated previously with another anti-VEGF drug.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| >= 70 letters<br>Baseline VA >= 70 letters | Drug: Aflibercept (Eylea, BAY86-5321)<br>* 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.<br>|
| 36-69 letters<br>Baseline VA 36-69 letters | Drug: Aflibercept (Eylea, BAY86-5321)<br>* 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.<br>|
| <=35 letters<br>Baseline VA <=35 letters | Drug: Aflibercept (Eylea, BAY86-5321)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |