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

Completed

• Conditions: Wet Age-related Macular Degeneration
• Interventions: Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)

• Registration Number: NCT01914380
• Lead Sponsor: Bayer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-07-23
• Study Start: 2013-07-29
• Study First Submitted QC: 2013-07-31
• Study First Posted: 2013-08-02
• Primary Completion: 2017-03-31
• Study Completion: 2017-03-31
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-27
• Last Update Posted: 2018-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 988

Inclusion Criteria

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

Read More

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.

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)	-

Primary Outcome Measures

Name	Time	Method
Mean change of visual acuity for the total patient population	Baseline, 12 and 24 months
Mean change of visual acuity for the subgroup of pretreated patients	Baseline, 12 and 24 months
Mean change of visual acuity for the subgroup of non-pretreated patients	Baseline, 12 and 24 months

Secondary Outcome Measures

Name	Time	Method
Monitoring of disease activity	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
Monitoring of treatment patterns	after 12 and 24 months	same assessment as indicated for "Monitoring of disease activity"
Mean time from indication of Eylea-treatment by the treating physician to start of treatment	after 12 and 24 months