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Completed

NCT Number: NCT01914380

Investigating the Effectiveness of Eylea in Patients With Wet Age-related Macular Degeneration

The study aims to investigate the effectiveness of Eylea in patients with wet age-related macular degeneration in routine clinical practice in Germany. The study is purely observational, only data from routine treatment are to be collected. The treatment and treatment conditions are solely at discretion of the treating physician.

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Key information

Conditions

Wet Age-related Macular Degeneration

Sex eligibility

All sexes

Study type

Observational

Primary location

Multiple Locations, Germany

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with wet wAMD treated with Eylea (in accordance with the local Summary of Product Characteristics, SPC).
  • Written informed consent.

Exclusion criteria

  • Exclusion criteria as listed in the local SPC.
  • Scar, fibrosis, or atrophy involving the center of the fovea in the study eye.
  • Any concomitant therapy with another agent to treat wet AMD in the study eye.

Treatment and study plan

Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)

Drug

Patients will be followed-up for 24 months

Primary outcomes

  1. Mean change of visual acuity for the total patient population

    Time frame: Baseline, 12 and 24 months

  2. Mean change of visual acuity for the subgroup of pretreated patients

    Time frame: Baseline, 12 and 24 months

  3. Mean change of visual acuity for the subgroup of non-pretreated patients

    Time frame: Baseline, 12 and 24 months

Secondary outcomes

  1. Monitoring of disease activity

    Time frame: after 12 and 24 months

    Monitoring of disease activity in routine clinical practice setting will be assessed e.g. by determining the o No. of clinical visits (visits for injections) o No. of monitoring visits (visits only for diagnostic purposes, but without injections) o No. of safety visits after the injection (visits only for safety checks after injection) o No. of visits outside the study center o No. of OCT (optical coherence tomography) assessments per patient after 12 and 24 months

  2. Monitoring of treatment patterns

    Time frame: after 12 and 24 months

    same assessment as indicated for "Monitoring of disease activity"

  3. Mean time from indication of Eylea-treatment by the treating physician to start of treatment

    Time frame: after 12 and 24 months

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Collaborators

  • Regeneron Pharmaceuticals

Registry information

Official study title

PERSEUS - A Prospective Non-interventional Study to Assess the Effectiveness of Aflibercept (Eylea®) in Routine Clinical Practice in Patients With Wet Age-related Macular Degeneration

Acronym: PERSEUS

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Aug 2, 2013
Registry last updated
Mar 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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