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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Wet Age-related Macular Degeneration

Intervention / Treatment
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* Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br> | Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)<br>* Patients will be followed-up for 24 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Monitoring of treatment patterns | same assessment as indicated for Monitoring of disease activity | after 12 and 24 months | 
| Mean time from indication of Eylea-treatment by the treating physician to start of treatment |  | after 12 and 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Wet age-related macular degeneration, Anti-VEGF-Therapy, Observational study