This trial is active, not recruiting.

Condition wet macular degeneration
Treatment aflibercept (eylea, vegf trap-eye, bay86-5321)
Sponsor Bayer
Collaborator Regeneron Pharmaceuticals
Start date October 2014
End date April 2019
Trial size 596 participants
Trial identifier NCT02279537, 17374, EY1411FR


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
According to the recommendations of the Summary of Product Characteristics (SmPC)
aflibercept (eylea, vegf trap-eye, bay86-5321)
Administration by intravitreal injection

Primary Outcomes

Change in the measurement of best-corrected visual acuity (BCVA) from baseline to 12 months.
time frame: Baseline to 12 months

Secondary Outcomes

Change in Best Corrected Visual Acuity (BCVA) during the second year and until the fourth year of treatment versus the initial visit
time frame: 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)
time frame: 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
time frame: Baseline to 1 year, 2 year, 3 year, 4 year

Eligibility Criteria

Male or female participants at least 18 years old.

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; 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.

Additional Information

Official title A Retrospective and Prospective Non-interventional Open Label Study to Assess the Real Life of Treatment-naive Patients With Wet Age-related Macular Degeneration in Routine Clinical Practice in France and Starting an Anti VEGF Therapy With Aflibercept
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
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Bayer.