To Describe the Use of Intravitreal Aflibercept and to Describe Follow-up as Well as Treatment Patterns in Patients With Wet Age-related Macular Degeneration (wAMD) or Diabetic Macular Edema (DME) in Routine Clinical Practice in Canada.
NCT ID: NCT02540369
Last Updated: 2019-02-15
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
2150 participants
OBSERVATIONAL
2015-12-14
2018-01-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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BAY86-5321- with wAMD
Patients with wet Age Related Macular Degeneration (wAMD) both naïve and previously treated patients
Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
Administration by intravitreal injection.Muti-target Anti-VEGF agent. Dosing would be at physicians discretion.
BAY86-5321 - with DME
Patients with Diabetic Macular Edema (DME) both naïve and previously treated patients
Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
Administration by intravitreal injection.Muti-target Anti-VEGF agent. Dosing would be at physicians discretion.
Interventions
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Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
Administration by intravitreal injection.Muti-target Anti-VEGF agent. Dosing would be at physicians discretion.
Eligibility Criteria
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Inclusion Criteria
* Male or female
* Patients with wet AMD (wet age-related macular degeneration) or Diabetic macular edema (DME) who will be treated by intravitreal aflibercept according to the Canadian Product monograph recommendations and routine clinical practice.
* Decision to treat with intravitreal aflibercept prior to patient enrolment as per the physician's routine clinical practice.
Exclusion Criteria
* Patients currently being treated with intravitreal aflibercept. This study will only include patients new to intravitreal aflibercept, both naïve and previously treated with other anti-VEGF therapies.
* Patients who are hypersensitive to this drug, to any ingredient in the formulation, or to any component of the container.
* Patients who are hypersensitive to this drug, to any ingredient in the formulation, or to any component of the container.
* Ocular or peri-ocular infection
* Active intraocular inflammation
* Scar, fibrosis, or atrophy involving the center of the fovea in the study eye.
* Any concomitant therapy with another agent to treat wet AMD or DME in the study eye.
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, , Canada
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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17995
Identifier Type: -
Identifier Source: org_study_id
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