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

Completed

• Conditions: Wet Macular Degeneration
• Interventions: Drug: Aflibercept (Eylea, BAY86-5321)

• Registration Number: NCT03278262
• Lead Sponsor: Bayer

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-08-28
• Study Start: 2017-09-01
• Study First Submitted QC: 2017-09-08
• Study First Posted: 2017-09-11
• Primary Completion: 2017-12-31
• Study Completion: 2017-12-31
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-26
• Last Update Posted: 2018-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2312

Inclusion Criteria

• Treatment-naïve eyes with neovascularization AMD, with the indication to be treated with Aflibercept. One and/or two eyes per patient.

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Exclusion Criteria

• Eyes treated previously with another anti-VEGF drug.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
>= 70 letters	Aflibercept (Eylea, BAY86-5321)	Baseline VA \>= 70 letters
36-69 letters	Aflibercept (Eylea, BAY86-5321)	Baseline VA 36-69 letters
<=35 letters	Aflibercept (Eylea, BAY86-5321)	Baseline VA \<=35 letters

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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)
Proportion of patients with no need of Vision Aid support	Up to 2 years

Trial Locations

Locations (1)

Many locations; 🇸🇪 Lund, Sweden