Wet Macular Degeneration
Conditions
Brief summary
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.
Interventions
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.
Sponsors
Regeneron Pharmaceuticals
Bayer
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Visual Acuity (VA) (Snellen) | at 3±1 months, 6±1months, 12±2 months and at 24±2 months follow-up | 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. |
| Change in Early Treatment Diabetic Retinopathy Study (ETDRS) | at 3±1 months, 6±1months, 12±2 months and at 24±2 months follow-up | Change Early Treatment Diabetic Retinopathy Study (ETDRS) in all eyes and stratified in the three groups by VA at baseline. |
| Change in Lasbarhetsindex (LIX, Readability Index) | at 3±1 months, 6±1months, 12±2 months and at 24±2 months follow-up | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | At year 1 and year 2 | 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 |
| Proportion of patients with no need of Vision Aid support | Up to 2 years | — |
| Proportion of patients that recuperate 20/20 vision (driving vision) in all patients and stratified by baseline VA (groups 1-3) | Up to 2 years | In all patients and stratified by baseline VA (groups 1-3) |
| Proportion of patients that recuperate 20/40 vision (driving vision) in all patients and stratified by baseline VA (groups 1-3) | Up to 2 years | In all patients and stratified by baseline VA (groups 1-3) |
Countries
Sweden
Outcome results
None listed