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

Wet Macular Degeneration Clinical Trial

— INSIGHT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03278262
• Other study ID #: 19473
• Status: Completed
• Start date: September 1, 2017
• Est. completion date: December 31, 2017

Study information

• Verified date: October 2018
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2312
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Macular Degeneration
• Wet Macular Degeneration

Intervention

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.

Locations

Country	Name	City	State
Sweden	Many locations	Lund

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	Regeneron Pharmaceuticals

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	Proportion of patients with no need of Vision Aid support		Up to 2 years

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