Real Life of Aflibercept In FraNce: oBservatiOnnal Study in Wet AMD
NCT ID: NCT02279537
Last Updated: 2023-11-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
593 participants
OBSERVATIONAL
2014-01-02
2019-04-17
Brief Summary
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Detailed Description
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Patients will be followed up for a period of 48 months or until it is no longer possible
Conditions
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Study Design
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COHORT
OTHER
Study Groups
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Cohort 1
According to the recommendations of the Summary of Product Characteristics (SmPC)
Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
Administration by intravitreal injection
Interventions
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Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
Administration by intravitreal injection
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Regeneron Pharmaceuticals
INDUSTRY
Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Multiple Locations, , France
Countries
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References
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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.
Weber 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.
Weber 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.
Weber 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.
Related Links
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Click here to find results for studies related to Bayer Healthcare products.
Other Identifiers
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EY1411FR
Identifier Type: OTHER
Identifier Source: secondary_id
17374
Identifier Type: -
Identifier Source: org_study_id
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