Real Life of Aflibercept In FraNce: oBservatiOnnal Study in Wet AMD
RAINBOW
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
2 other identifiers
observational
593
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2014
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 2, 2014
CompletedFirst Submitted
Initial submission to the registry
October 29, 2014
CompletedFirst Posted
Study publicly available on registry
October 31, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 17, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 17, 2019
CompletedNovember 7, 2023
November 1, 2023
5.3 years
October 29, 2014
November 3, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in the measurement of best-corrected visual acuity (BCVA) from baseline to 12 months.
As assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) method or any visual logarithmic scale
Baseline to 12 months
Secondary Outcomes (3)
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
Study Arms (1)
Cohort 1
According to the recommendations of the Summary of Product Characteristics (SmPC)
Interventions
Eligibility Criteria
Naïve treatment patients with wet AMD who started a treatment with Anti VEGF (Vascular Endothelial Growth Factor) may be included in the study
You may qualify if:
- 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;
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
- Regeneron Pharmaceuticalscollaborator
Study Sites (1)
Unknown Facility
Multiple Locations, France
Related Publications (4)
Cohen SY, Dominguez M, Coscas F, Faure C, Baillif S, Oubraham H, Kodjikian L, Weber M; RAINBOW study investigators. Final 4-year results of the RAINBOW real-world study: intravitreal aflibercept dosing regimens in France in treatment-naive patients with neovascular age-related macular degeneration. Graefes Arch Clin Exp Ophthalmol. 2023 Apr;261(4):959-969. doi: 10.1007/s00417-022-05900-6. Epub 2022 Nov 18.
PMID: 36399178RESULTWeber M, Kodjikian L, Coscas F, Faure C, Aubry I, Dufour I, Cohen SY. Impact of intravitreal aflibercept dosing regimens in treatment-naive patients with neovascular age-related macular degeneration in routine clinical practice in France: results from the RAINBOW study. BMJ Open Ophthalmol. 2020 Apr 6;5(1):e000377. doi: 10.1136/bmjophth-2019-000377. eCollection 2020.
PMID: 32518833DERIVEDWeber M, Dominguez M, Coscas F, Faure C, Baillif S, Kodjikian L, Cohen SY. Impact of intravitreal aflibercept dosing regimens in treatment-naive patients with neovascular age-related macular degeneration: 2-year results of RAINBOW. BMC Ophthalmol. 2020 May 25;20(1):206. doi: 10.1186/s12886-020-01468-z.
PMID: 32450838DERIVEDWeber M, Velasque L, Coscas F, Faure C, Aubry I, Cohen SY; RAINBOW study investigators. Effectiveness and safety of intravitreal aflibercept in patients with wet age-related macular degeneration treated in routine clinical practices across France: 12-month outcomes of the RAINBOW study. BMJ Open Ophthalmol. 2019 Apr 9;4(1):e000109. doi: 10.1136/bmjophth-2017-000109. eCollection 2019.
PMID: 31179386DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 29, 2014
First Posted
October 31, 2014
Study Start
January 2, 2014
Primary Completion
April 17, 2019
Study Completion
April 17, 2019
Last Updated
November 7, 2023
Record last verified: 2023-11