Aflibercept (Eylea) in roUtine Clinical Practice in patientS With Wet Age-related Macular Degeneration in Italy

Completed

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

• Registration Number: NCT02289924
• Lead Sponsor: Bayer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-11-10
• Study First Submitted QC: 2014-11-10
• Study First Posted: 2014-11-13
• Study Start: 2015-01-09
• Primary Completion: 2019-03-28
• Study Completion: 2019-07-08
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-03
• Last Update Posted: 2023-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 912

Inclusion Criteria

• "Naïve" patients with wet AMD(age-related macular degeneration) treated with Eylea (in accordance with the local Summary of Product Characteristics, SPC).

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort 1	Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)	According to the recommendations of the Summary of Product Characteristics (SmPC) in Italy

Primary Outcome Measures

Name	Time	Method
Mean change of visual acuity from baseline to 12 months.	Baseline to 12 months
Mean change of visual acuity from baseline to 24 months.	Baseline to 24 months

Secondary Outcome Measures

Name	Time	Method
Number of post-injection monitoring visits (visits only for safety checks after injection)	At 12 and 24 months
Mean time between the first symptoms and diagnosis	Up to 24 months
Mean time from indication of the Eylea treatment by the treating physician to treatment	Up to 24 months	Time will be defined as difference in days between clinical indication for the treatment and the first injection
Mean change in retinal thickness from baseline	Baseline and at 4,12 and 24 months	As measured by OCT (SD-SLO) Optical Coherence Tomography ( Spectral Domain / Scanning Laser Ophthalmoscope)
Number of clinical visits (visits for injections)	At 12 and 24 months
Number of monitoring visits (visits only for diagnostic purposes, but without injections)	At 12 and 24 months
Number of combined visits (visits for monitoring and injection)	At 12 and 24 months
Number of visits outside the study center after 12 and 24 months	At 12 and 24 months
Number of optical coherence tomography (OCT) assessments per patient	At 12 and 24 months
Number of visual acuity tests	At 12 and 24 months
Number of fundoscopy examinations	At 12 and 24 months
Mean time between the injections and visits	At 12 and 24 months
Proportion of patients with no fluid	At 4,12 and 24 months