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

NCT ID: NCT02279537

Last Updated: 2023-11-07

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

593 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-02

Study Completion Date

2019-04-17

Brief Summary

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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

Detailed Description

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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

Conditions

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Wet Macular Degeneration

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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)

Intervention Type DRUG

Administration by intravitreal injection

Interventions

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

Administration by intravitreal injection

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role collaborator

Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Multiple Locations, , France

Site Status

Countries

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France

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.

Reference Type RESULT
PMID: 36399178 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32518833 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32450838 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31179386 (View on PubMed)

Related Links

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https://clinicaltrials.bayer.com/

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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