check_circleStudy Completed

Wet Macular Degeneration

Bayer Identifier:

19473

ClinicalTrials.gov Identifier:

NCT03278262

EudraCT Number:

Not Available

EU CT Number:

Not Available
The impact of baseline visual acuity on the treatment outcomes in patients treated with AflIbercept in real-life clinical setting

Trial purpose

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.

Key Participants Requirements

Sex

All

Age

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

  • -Eyes treated previously with another anti-VEGF drug.

Trial summary

Enrollment Goal
2312
Trial Dates
September 2017 - December 2017
Phase
N/A
Could I Receive a placebo
No
Products
Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many locationsLund, Sweden

Primary Outcome

  • 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.
    date_rangeTime 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.
    date_rangeTime 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
    date_rangeTime Frame:
    at 3±1 months, 6±1months, 12±2 months and at 24±2 months follow-up

Secondary Outcome

  • 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
    date_rangeTime 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)
    date_rangeTime 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)
    date_rangeTime Frame:
    Up to 2 years
  • Proportion of patients with no need of Vision Aid support
    date_rangeTime Frame:
    Up to 2 years

Trial design

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
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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