Real Life of Aflibercept in France in Patients Refractory to Ranibizumab: Observational Study in Wet AMD
NCT ID: NCT02321241
Last Updated: 2018-07-02
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
236 participants
OBSERVATIONAL
2016-02-01
2017-08-18
Brief Summary
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The study will be conducted in real-life conditions and will allow describing conditions of use of aflibercept in patients refractory to ranibizumab
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Detailed Description
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The observation periods starts on January 2014. Patients who initiated a treatment by Aflibercept between the 1st of january 2014 and the 31 December 2015 will be enrolled.
Conditions
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Study Design
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COHORT
OTHER
Study Groups
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Group 1
According to the recommendations of the Summary of Products Characteristics (SmPC) Administration by intravitreal injection
Aflibercept (EYLEA, BAY-86-5321)
1. st year: 3 monthly injections followed by 1 injection every two months
2. nd year and following: injection according the visual and anatomical results observed the 1st year
Interventions
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Aflibercept (EYLEA, BAY-86-5321)
1. st year: 3 monthly injections followed by 1 injection every two months
2. nd year and following: injection according the visual and anatomical results observed the 1st year
Eligibility Criteria
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Inclusion Criteria
* Patient with wAMD previously treated with ranibizumab (for less than 12 months before initiation of Aflibercept)
* Refractory to ranibizumab (defined by persistent fluid despite a treatment conducted according to the HAS French recommendations with at least 3 loading doses injections)
* Patient who switched to aflibercept (Eylea) between 1st of January 2014 and 30th June 2015
* Written informed consent given
Exclusion Criteria
* Recurrent patients with wAMD previously treated with ranibizumab and switched to aflibercept because of a high recurrence rate (recurrent patients described by Yonegawa et al.in AJO (American Journal of Ophthalmology )2013= exudation suppressed but high rate of injections)
* Patient who have been previously treated by any macular laser Visudyne/PD (Photodynamic therapy)
* Patient with a Visual Acuity (VA) \<1/10
* Patient with Fibrosis involving Macula
* Patient with atrophic AMD
* Patient with any other retinal disease as myopia, diabetic retinopathy, diabetic macular oedema,chorioretinal anastomosis (CRA),, angioid streaks
* Patients 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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Razavi S, Kodjikian L, Giocanti-Auregan A, Dufour I, Souied E. Efficacy and safety of intravitreal aflibercept in ranibizumab-refractory patients with neovascular age-related macular degeneration. BMC Ophthalmol. 2021 Feb 17;21(1):90. doi: 10.1186/s12886-021-01841-6.
Other Identifiers
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EY1413FR
Identifier Type: OTHER
Identifier Source: secondary_id
17405
Identifier Type: -
Identifier Source: org_study_id
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