Observational Study to Assess Intravitreal Aflibercept Injections Used in a "Treat and Extend" Regimen in Treatment-naïve Wet Age-related Macular Degeneration Patients
NCT ID: NCT03382587
Last Updated: 2023-06-05
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
163 participants
OBSERVATIONAL
2017-12-05
2018-11-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
OTHER
Study Groups
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Aflibercept
Treatment-naive wet age-related macular degeneration patients under routine intravitreal aflibercept treatment in a treat-and-extend scheme
Aflibercept (Eylea, BAY86-5321)
Intravitreal aflibercept injections used in a routine "treat and extend" regimen, under which the intervals between the injections are extended if disease stability is maintained and no signs of worsening disease are observed on the injection day
Interventions
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Aflibercept (Eylea, BAY86-5321)
Intravitreal aflibercept injections used in a routine "treat and extend" regimen, under which the intervals between the injections are extended if disease stability is maintained and no signs of worsening disease are observed on the injection day
Eligibility Criteria
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Inclusion Criteria
* No prior therapy for wet age-related macular degeneration.
* Patients for whom the decision to initiate treatment with IVT-AFL in a T\&E regimen was made as per routine clinical practice.
* Patient age \>55 years of age
Exclusion Criteria
* Patients with eye diseases e.g. advanced glaucoma or visually significant cataracts, likely to require surgery during the observation period in the study eye.
* Concomitant ocular or systemic administration of drugs up to 3 months before commencement of IVT-AFL treatment that could interfere with or potentiate the mechanism of action of aflibercept, including anti-VEGF agents. This includes patients receiving a different anti-VEGF agent for the fellow eye
55 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, , Switzerland
Countries
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Related Links
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Click here to find results for studies related to Bayer Healthcare products.
Other Identifiers
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18574
Identifier Type: -
Identifier Source: org_study_id
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