Trial Condition(s):
Wet Macular Degeneration
Aflibercept (Eylea) in roUtine clinical practice in patientS with wet age-related macular degeneration in Italy (PERSEUS–IT)
Bayer Identifier:
17634
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
The main objectives of this non-interventional cohort field study are to evaluate effectiveness of Eylea and to describe follow-up as well as treatment patterns in patients with wAMD (wet age-related macular degeneration) in routine clinical practice in Italy for a study population of “naïve” patients
Inclusion Criteria
- “Naïve” patients with wet AMD(age-related macular degeneration) treated with Eylea (in accordance with the local Summary of Product Characteristics, SPC).
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. - Any prior or concomitant therapy with another drug for wAMD.
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, Italy | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Trial Design
PERSEUS-IT. A Prospective non-intERventional study to asSEss the effectiveness of Aflibercept (Eylea®) in roUtine clinical practice in patientS with wet age-related macular degeneration in Italy
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 from baseline to 12 months.Timeframe: Baseline to 12 months
- Mean change of visual acuity from baseline to 24 months.Timeframe: Baseline to 24 months
Secondary Outcome
- Number of clinical visits (visits for injections)Timeframe: At 12 and 24 months
- Number of monitoring visits (visits only for diagnostic purposes, but without injections)Timeframe: At 12 and 24 months
- Number of combined visits (visits for monitoring and injection)Timeframe: At 12 and 24 months
- Number of post-injection monitoring visits (visits only for safety checks after injection)Timeframe: At 12 and 24 months
- Number of visits outside the study center after 12 and 24 monthsTimeframe: At 12 and 24 months
- Number of optical coherence tomography (OCT) assessments per patientTimeframe: At 12 and 24 months
- Number of visual acuity testsTimeframe: At 12 and 24 months
- Number of fundoscopy examinationsTimeframe: At 12 and 24 months
- Mean time between the injections and visitsTimeframe: At 12 and 24 months
- Mean time between the first symptoms and diagnosisTimeframe: Up to 24 months
- Mean time from indication of the Eylea treatment by the treating physician to treatmentTime will be defined as difference in days between clinical indication for the treatment and the first injectionTimeframe: Up to 24 months
- Proportion of patients with no fluidTimeframe: At 4,12 and 24 months
- Mean change in retinal thickness from baselineAs measured by OCT (SD-SLO) Optical Coherence Tomography ( Spectral Domain / Scanning Laser Ophthalmoscope)Timeframe: Baseline and at 4,12 and 24 months
Additional Information
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