A Study in Patients With Wet Age-related Macular Degeneration or Diabetic Macular Edema to Assess the freQuency of Use of Intravitreal Aflibercept in Routine Clinical Practices in Latin America
NCT ID: NCT03470103
Last Updated: 2021-06-25
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
643 participants
OBSERVATIONAL
2018-03-28
2021-01-15
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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Treatment naïve wAMD
The decision regarding treatment is made at the discretion of the attending physician, according to his/her medical practice
Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)
Use of intravitreal aflibercept in routine clinical practice in Latin America
Treatment naïve DME
The decision regarding treatment is made at the discretion of the attending physician, according to his/her medical practice
Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)
Use of intravitreal aflibercept in routine clinical practice in Latin America
Previously treated wAMD
The decision regarding treatment is made at the discretion of the attending physician, according to his/her medical practice
Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)
Use of intravitreal aflibercept in routine clinical practice in Latin America
Previously treated DME
The decision regarding treatment is made at the discretion of the attending physician, according to his/her medical practice
Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)
Use of intravitreal aflibercept in routine clinical practice in Latin America
Interventions
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Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)
Use of intravitreal aflibercept in routine clinical practice in Latin America
Eligibility Criteria
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Inclusion Criteria
* Age: ≥55 for wAMD patients
* Decision to treat with intravitreal aflibercept in the study eye prior to patient enrolment as per the physician's routine clinical practice and following the local Product monograph recommendations. Patients who are treatment naïve (no previous intravitreal treatment received, including, anti- VEGF agents, steroids, steroid implants and/or PDT) and patients that are switching from a different anti-VEGF therapy are both eligible to be included. DME patients that have received previous laser only will be classified as treatment naïve.
* 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 currently being treated with intravitreal aflibercept in the study eye.
* Patients who are hypersensitive to this drug, to any ingredient in the formulation, or to any component of the container. For a complete listing, see the DOSAGE FORMS, COMPOSITION AND PACKAGING section of the local product monograph.
* Ocular or peri-ocular infection in either eye.
* Active intraocular inflammation in the study eye.
* Scar, fibrosis, or atrophy involving the center of the fovea in the study eye.
* Patients with advanced glaucoma, visually significant cataracts, or any eye disease likely to require surgery during the study period in the study eye.
* Concomitant ocular or systemic administration of drugs that could interfere with or potentiate the mechanism of action of intravitreal aflibercept, including anti-VEGF agents.
* Patients receiving a different anti-VEGF agent other than intravitreal aflibercept for the fellow eye.
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, , Argentina
Many locations
Multiple Locations, , Colombia
Many locations
Multiple Locations, , Costa Rica
Many locations
Multiple Locations, , Mexico
Countries
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References
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Wu L, Bordon AF, Charles M, Rodriguez FJ, Lee J, Machewitz T, Mueller M, Del Carmen Gay G, Fromow-Guerra J; AQUILA investigators. Intravitreal aflibercept for the treatment of patients with neovascular age-related macular degeneration in routine clinical practice in Latin America: the AQUILA study. Int J Retina Vitreous. 2022 Oct 18;8(1):76. doi: 10.1186/s40942-022-00425-w.
Rodriguez FJ, Wu L, Bordon AF, Charles M, Lee J, Machewitz T, Mueller M, Gay GDC, Fromow-Guerra J; AQUILA Investigators. Intravitreal aflibercept for the treatment of patients with diabetic macular edema in routine clinical practice in Latin America: the AQUILA study. Int J Retina Vitreous. 2022 Aug 2;8(1):52. doi: 10.1186/s40942-022-00396-y.
Other Identifiers
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19518
Identifier Type: -
Identifier Source: org_study_id
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