check_circleStudy Completed

Wet age-related macular degeneration

Bayer Identifier:

16623

ClinicalTrials.gov Identifier:

NCT01914380

EudraCT Number:

Not Available

EU CT Number:

Not Available
Investigating the effectiveness of Eylea in patients with wet age-related macular degeneration

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

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

  • - 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.

Trial summary

Enrollment Goal
988
Trial Dates
July 2013 - March 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 Locations, Germany

Primary Outcome

  • Mean change of visual acuity for the total patient population
    date_rangeTime Frame:
    Baseline, 12 and 24 months
    enhanced_encryption
    Safety Issue:
    No
  • Mean change of visual acuity for the subgroup of pretreated patients
    date_rangeTime Frame:
    Baseline, 12 and 24 months
    enhanced_encryption
    Safety Issue:
    No
  • Mean change of visual acuity for the subgroup of non-pretreated patients
    date_rangeTime Frame:
    Baseline, 12 and 24 months
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Monitoring of disease activity
    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
    date_rangeTime Frame:
    after 12 and 24 months
    enhanced_encryption
    Safety Issue:
    No
  • Monitoring of treatment patterns
    same assessment as indicated for "Monitoring of disease activity"
    date_rangeTime Frame:
    after 12 and 24 months
    enhanced_encryption
    Safety Issue:
    No
  • Mean time from indication of Eylea-treatment by the treating physician to start of treatment
    date_rangeTime Frame:
    after 12 and 24 months
    enhanced_encryption
    Safety Issue:
    No

Trial design

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
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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