Assessment of Proactive Treatments in Patients With Wet Age-related Macular Degeneration (wAMD) Which Have Never Undergone Treatment of This Particular Disease
NCT ID: NCT03939767
Last Updated: 2024-09-20
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
1563 participants
OBSERVATIONAL
2019-05-12
2023-10-17
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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wAMD patients
Patients with a diagnosis of wAMD and naïve to any treatment in the study eye will be enrolled after the decision by treating physician for IVT aflibercept therapy according to the local label.
Aflibercept (Eylea, BAY86-5321)
As prescribed by the treating physician according to the local label. No IVT aflibercept will be provided due to a nature of observational study.
Interventions
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Aflibercept (Eylea, BAY86-5321)
As prescribed by the treating physician according to the local label. No IVT aflibercept will be provided due to a nature of observational study.
Eligibility Criteria
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Inclusion Criteria
* Patients for whom the decision to initiate treatment with IVT aflibercept in a proactive regimen was made as routine clinical practice.
* Treatment-naïve in the study eye (no prior therapy for wAMD).
* Patient age ≥50 years of age.
* Written informed patient consent before the start of data collection (according to the requirements of the local authorities and laws).
Exclusion Criteria
* Patients with contraindications to IVT aflibercept listed in the local marketing authorization.
* Planned treatment regimen outside of the local marketing authorization.
* 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 IVT aflibercept treatment that could interfere with or potentiate the mechanism of action of IVT aflibercept, including other anti-VEGF agents in the fellow eye.
* Any other retinal disease which may interfere with the treatment of wAMD.
50 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, , Australia
Many Locations
Multiple Locations, , Belgium
Many Locations
Multiple Locations, , Canada
Many Locations
Multiple Locations, , China
Many Locations
Multiple Locations, , Colombia
Many Locations
Multiple Locations, , Denmark
Many Locations
Multiple Locations, , France
Many Locations
Multiple Locations, , Ireland
Many Locations
Multiple Locations, , Italy
Many Locations
Multiple Locations, , Norway
Many Locations
Multiple Locations, , South Korea
Many Locations
Multiple Locations, , Spain
Many Locations
Multiple Locations, , Sweden
Many Locations
Multiple Locations, , Switzerland
Many Locations
Multiple Locations, , Thailand
Many Locations
Multiple Locations, , United Kingdom
Countries
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References
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Bailey C, Chandran M, Gale R, Narendran N, Talks J, McGoey H, Keshk Z, Morgan-Warren P, Allmeier H, Machewitz T, Patel PJ, Varma D. 2-year results from an observational study of proactive treatment regimens with intravitreal aflibercept 2 mg in patients with nAMD in clinical practice: XTEND study UK cohort. Eye (Lond). 2025 Apr;39(6):1138-1145. doi: 10.1038/s41433-024-03550-y. Epub 2024 Dec 24.
Korobelnik JF, Chaudhary V, Mitchell P, Kang SW, Tadayoni R, Allmeier H, Lee J, Zhang X, Machewitz T, Bailey C. XTEND: Two-Year Results from a Global Observational Study Investigating Proactive Dosing of Intravitreal Aflibercept in Neovascular Age-Related Macular Degeneration. Ophthalmol Ther. 2024 Mar;13(3):725-738. doi: 10.1007/s40123-023-00867-x. Epub 2024 Jan 10.
Related Links
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Click here to find further information and, after study completion, the study results according to Bayer's transparency standards
Other Identifiers
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20359
Identifier Type: -
Identifier Source: org_study_id
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