An observational study in Wet Macular Degeneration, sponsored by Bayer. Completed at 1 site in Sweden. Per ClinicalTrials.gov, last updated 2018-10-29.
Sponsored by Bayer · Observational
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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.
93 studies on the registry are indexed under Wet Macular Degeneration; 10 are open to participants now.
This study's enrollment of 2,312 is above the median of 72 across 17 observational studies indexed under Wet Macular Degeneration.
Browse Wet Macular Degeneration studies →Bayer is the lead sponsor of 1,674 studies on the registry; 51 are open to participants now.
Of its 214 completed or terminated interventional studies of FDA-regulated products, 132 (62%) have results posted.
Counted across the registry records on this site, refreshed daily.
All patients registered in the Swedish Macula Register during the study period.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Baseline VA \>= 70 letters
Drug: Aflibercept (Eylea, BAY86-5321)
Baseline VA 36-69 letters
Drug: Aflibercept (Eylea, BAY86-5321)
Baseline VA \<=35 letters
Drug: Aflibercept (Eylea, BAY86-5321)
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.
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.
Time frame: 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.
Time frame: 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
Time frame: at 3±1 months, 6±1months, 12±2 months and at 24±2 months follow-up
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
Time frame: 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)
Time frame: 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)
Time frame: Up to 2 years
Proportion of patients with no need of Vision Aid support
Time frame: Up to 2 years
Ran from Sep 2017 to primary completion in Dec 2017, 3 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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