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

Bayer

Status: Completed

Conditions: Wet Macular Degeneration

Treatments: Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)

Study type: Observational

Funder types: Industry

Identifiers

NCT02279537

EY1411FR (Other Identifier)

17374

Details and patient eligibility

About

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

Full 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

Enrollment: 593 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

593 participants in 1 patient group

Cohort 1

Description:

According to the recommendations of the Summary of Product Characteristics (SmPC)

Treatment:

Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)