Evaluate the Effectiveness of Intravitreal (IVT) Aflibercept Injection in Clinical Practice in naïve Patients With Neovascular Age-related Macular Degeneration (nAMD)
NCT ID: NCT03411941
Last Updated: 2019-12-05
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
116 participants
OBSERVATIONAL
2018-02-28
2019-03-01
Brief Summary
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The aim of this study is to collect 12-month real-world clinical data from treatment-naïve nAMD patients who started first-line treatment with IVT aflibercept injection, according to the SmPC (Summary of Product Characteristics) and the SERV (Spanish Society of Retina and Vitreous) guidelines. The effectiveness of IVT aflibercept will be assessed by the changes in VA (Visual Acuity) and CRT (Central Retinal Thickness) during treatment.
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Treatment-naïve nAMD patients
Patient data for whom treatment with IVT aflibercept injection was initiated as first-line treatment according to the SmPC and the SERV Guideline, in treatment-naive patients with newly diagnosed of nAMD in routine clinical practice.
Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)
IVT(Intravitreal) aflibercept treatment in routine clinical practice.
Interventions
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Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)
IVT(Intravitreal) aflibercept treatment in routine clinical practice.
Eligibility Criteria
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Inclusion Criteria
* Treatment-naïve patients with nAMD
* Patients who initated treatment with IVT aflibercept injection between 1st April 2014 to 31st May 2016
* Patients that have been decided to be treated with IVT aflibercept with a minimum treatment follow-up with IVT aflibercept injection of at least 12-months, in accordance with the approved SmPC.
* Patients who have been provided with appropriate information about the study objectives and procedures and who have given their written informed consent.
Exclusion Criteria
* Patients that switched to another treatment alternative different from IVT aflibercept injection during observation period of 12 months
* Patients with another retinal disease: diabetic retinopathy, diabetic macular edema (DME), myopic choroidal neovascularization, retinal vein occlusion (RVO), central serous chorioretinopathy (CSC), angioid streaks.
* Patients with scarring, fibrosis, or atrophy involving the center of the fovea in the study eye at treatment initiation
* Patients with advanced cataract or advanced glaucoma
* Patients with presence of retinal pigment epithelial tears or rips involving the macula in the study eye prior to treatment initiation.
* Patients who do not meet the local Guideline criteria for aflibercept treatment. Contraindications listed in the SmPC must be taken into account.
50 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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Many locations
Multiple Locations, , Spain
Countries
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Related Links
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Click here to find results for studies related to Bayer products.
Other Identifiers
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18798
Identifier Type: -
Identifier Source: org_study_id
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