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

Sponsor

Bayer (Industry)

Overall Status

Completed

CT.gov ID

NCT02279537

Collaborator

Regeneron Pharmaceuticals (Industry)

593

Enrollment

Location

63.4

Actual Duration (Months)

9.3

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Wet Macular Degeneration	Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)

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 Design

Study Type:

Observational

Actual Enrollment :

593 participants

Observational Model:

Cohort

Time Perspective:

Other

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

Actual Study Start Date :

Jan 2, 2014

Actual Primary Completion Date :

Apr 17, 2019

Actual Study Completion Date :

Apr 17, 2019

Arms and Interventions

Arm	Intervention/Treatment
Cohort 1 According to the recommendations of the Summary of Product Characteristics (SmPC)	Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321) Administration by intravitreal injection

Arm

Intervention/Treatment

Cohort 1

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

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

Administration by intravitreal injection

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.