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Completed

NCT Number: NCT03278262

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

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.

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Key information

Conditions

Wet Macular Degeneration Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Many locations

Lund, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Aflibercept (Eylea, BAY86-5321)

Drug

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.

Primary outcomes

  1. Change in Visual Acuity (VA) (Snellen)

    Time frame: 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.

  2. Change in Early Treatment Diabetic Retinopathy Study (ETDRS)

    Time frame: 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.

  3. Change in Lasbarhetsindex (LIX, Readability Index)

    Time frame: 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 outcomes

  1. 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

    Time frame: 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

  2. Proportion of patients that recuperate 20/20 vision (driving vision) in all patients and stratified by baseline VA (groups 1-3)

    Time frame: Up to 2 years

    In all patients and stratified by baseline VA (groups 1-3)

  3. Proportion of patients that recuperate 20/40 vision (driving vision) in all patients and stratified by baseline VA (groups 1-3)

    Time frame: Up to 2 years

    In all patients and stratified by baseline VA (groups 1-3)

  4. Proportion of patients with no need of Vision Aid support

    Time frame: Up to 2 years

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Collaborators

  • Regeneron Pharmaceuticals

Registry information

Official study 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

Acronym: INSIGHT

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Sep 11, 2017
Registry last updated
Oct 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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