Trial Condition(s):
Wet age-related macular degeneration
Investigating the effectiveness of Eylea in patients with wet age-related macular degeneration (PERSEUS)
Bayer Identifier:
16623
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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.
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.
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Many Locations, Germany | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
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:
1
Primary Outcome
- Mean change of visual acuity for the total patient populationTimeframe: Baseline, 12 and 24 months
- Mean change of visual acuity for the subgroup of pretreated patientsTimeframe: Baseline, 12 and 24 months
- Mean change of visual acuity for the subgroup of non-pretreated patientsTimeframe: Baseline, 12 and 24 months
Secondary Outcome
- Monitoring of disease activityMonitoring 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 monthsTimeframe: after 12 and 24 months
- Monitoring of treatment patternssame assessment as indicated for "Monitoring of disease activity"Timeframe: after 12 and 24 months
- Mean time from indication of Eylea-treatment by the treating physician to start of treatmentTimeframe: after 12 and 24 months
Additional Information
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