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

Sponsor
Bayer
Study ID
NCT03278262
Status
Completed

Conditions

  • Wet Macular Degeneration

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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 Dates

Start date
Sep 1, 2017
Status verified
Oct 2018
Primary completion
Dec 31, 2017
Completion
Dec 31, 2017

Study Design

Enrollment
2,312 participants (actual)

Arms

  • Arm: >= 70 letters
    Baseline VA \>= 70 letters
  • Arm: 36-69 letters
    Baseline VA 36-69 letters
  • Arm: <=35 letters
    Baseline VA \<=35 letters

Primary Outcome Measure

Change in Visual Acuity (VA) (Snellen) [ Time Frame: at 3±1 months, 6±1months, 12±2 months and at 24±2 months follow-up ]

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