Study to Gather Information on the Safety and Use of Aflibercept Injections Into the Eye for the Treatment of Eye Disorders in Mexican Routine Clinical Practice
NCT ID: NCT04137120
Last Updated: 2023-02-17
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
73 participants
OBSERVATIONAL
2021-02-19
2023-02-01
Brief Summary
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Detailed Description
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Secondary objectives comprise the comparison of the aflibercept safety profile between defined subgroups and the assessment of the real-world application of intravitreal aflibercept injections with special focus on CRVO, BRVO and mCNV indications.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients_Ocular disease
Adult patients treated for wet age-related macular degeneration (wAMD), or diabetic macular edema (DME), or macular edema secondary to central retinal vein occlusion (CRVO), or macular edema secondary to branch retinal vein occlusion (BRVO) or myopic choroidal neovascularization (mCNV) in routine clinical practice in Mexico (overall cohort)
Aflibercept (BAY86-5321, Eylea)
Intravitreal injection of aflibercept as scheduled by treating physician
Interventions
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Aflibercept (BAY86-5321, Eylea)
Intravitreal injection of aflibercept as scheduled by treating physician
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Decision to initiate treatment with intravitreal aflibercept was made as per investigator's routine treatment practice and independently of study inclusion;
* Treatment naïve or pre-treated for macular diseases (to anti-VEGF and steroid intravitreal treatments); patients who underwent laser photocoagulation and/or are being treated with panretinal photocoagulation therapies are eligible for study participation;
* If of childbearing potential, female willing to use effective contraception during treatment and for at least 3 months after the last intravitreal injection of aflibercept
Exclusion Criteria
* Patients that were already treated with anti-VEGF or steroids are allowed to be enrolled only if they received the last dose of anti-VEGF 3 or more months ago and in the case of a steroid implant 6 months after the last dose;
* Current treatment with other intravitreal therapies
* Contra-indications according to Eylea's / Wetlia's local marketing authorization:
* Ocular or periocular infection
* Active intraocular Inflammation
* Known hypersensitivity to aflibercept or to any of its excipients
* Pregnant or lactating women.
* Participation in an interventional study
18 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Locations
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Many locations
Multiple Locations, , Mexico
Countries
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Other Identifiers
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19212
Identifier Type: -
Identifier Source: org_study_id
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