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

Wet Age-related Macular Degeneration Clinical Trial

— PERSEUS  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01914380
• Other study ID #: 16623
• Secondary ID: EY1313DE
• Status: Completed
• First received: July 23, 2013
• Last updated: March 27, 2018
• Start date: July 29, 2013
• Est. completion date: March 31, 2017

Study information

• Verified date: March 2018
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 988
• Est. completion date: March 31, 2017
• Est. primary completion date: March 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Macular Degeneration
• Wet Age-related Macular Degeneration

Intervention

Drug:
• Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
Patients will be followed-up for 24 months

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	Regeneron Pharmaceuticals

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change of visual acuity for the total patient population		Baseline, 12 and 24 months
Primary	Mean change of visual acuity for the subgroup of pretreated patients		Baseline, 12 and 24 months
Primary	Mean change of visual acuity for the subgroup of non-pretreated patients		Baseline, 12 and 24 months
Secondary	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	after 12 and 24 months
Secondary	Monitoring of treatment patterns	same assessment as indicated for "Monitoring of disease activity"	after 12 and 24 months
Secondary	Mean time from indication of Eylea-treatment by the treating physician to start of treatment		after 12 and 24 months

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