Real Life of Aflibercept In FraNce: oBservatiOnnal Study in Wet AMD

Completed

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

• Registration Number: NCT02279537
• Lead Sponsor: Bayer

Brief Summary

The purpose of this study is to collect real-life data on patients with wet age related macular degeneration (AMD) for whom treatment with Eylea was initiated

Detailed Description

The study is both retrospective and prospective to collect local real life data on patients under routine treatment. The observation period starts on January 2014. Patients who have received the 1st injection with Eylea from January 2014 will be enrolled.

Patients will be followed up for a period of 48 months or until it is no longer possible

Study Timeline

• Study Start: 2014-01-02
• Study First Submitted: 2014-10-29
• Study First Submitted QC: 2014-10-29
• Study First Posted: 2014-10-31
• Primary Completion: 2019-04-17
• Study Completion: 2019-04-17
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-03
• Last Update Posted: 2023-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 593

Inclusion Criteria

• Patient with a diagnosis of wet AMD will be enrolled after the decision for treatment with Aflibercept (Eylea) has been made
• Patient with 1st injection of Eylea from 01 January 2014 until 30 April 2015 will be enrolled
• Prior/current treatment with any anti-VEGF intravitreal injections or macular laser (laser and/or visudyne/PDT) in the fellow eye is allowed
• Man or woman aged 18 years or more
• Patient who has been given appropriate information about the study objectives and procedures and who has given his/her written, informed consent;

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Exclusion Criteria

• Patient with another retinal disease: diabetic retinopathy, diabetic macular oedema (DME), myopic choroidal neovascularization, retinal vein occlusion (RVO), central serous chorioretinopathy (CSC), angioid streaks
• Patient who does not meet the local indication criteria for Eylea treatment.Contraindications listed in the Summary of Product Characteristics (SmPC) must be taken into account
• Patient who has previously been treated with any macular laser (laser and/or visudyne/PDT) or any anti-VEGF intravitreal injections for the study eye
• Patient taking part in an interventional study at the time of enrolment.

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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)

Primary Outcome Measures

Name	Time	Method
Change in the measurement of best-corrected visual acuity (BCVA) from baseline to 12 months.	Baseline to 12 months	As assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) method or any visual logarithmic scale

Secondary Outcome Measures

Name	Time	Method
Change in Best Corrected Visual Acuity (BCVA) during the second year and until the fourth year of treatment versus the initial visit	Baseline to 2 year, 3 year, 4 year
Percentage of patients who experienced a gain in BCVA, from initial visit to each follow-up visit (letter score of ≥ 0 letters, ≥ 5 letters, ≥ 10 letters, ≥ 15 letters)	Baseline to 1 year, 2 year, 3 year, 4 year
Percentage of patients losing fewer than 15 letters from the initial visit visual acuity at each follow-up visit	Baseline to 1 year, 2 year, 3 year, 4 year