Multiple Locations, France
NCT Number: NCT02279537
Real Life of Aflibercept In FraNce: oBservatiOnnal Study in Wet AMD
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
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Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
About this study
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
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
DrugAdministration 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
As assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) method or any visual logarithmic scale
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
Sponsors and collaborators
Lead sponsor
Bayer
Industry
Collaborators
- Regeneron Pharmaceuticals
Registry information
Official study 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
Acronym: RAINBOW
Important dates
- Study start
- 2014
- Primary completion
- 2019
- Study completion
- 2019
- First posted
- Oct 31, 2014
- Registry last updated
- Nov 7, 2023
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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