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Managing Neovascular Age-related Macular Degeneration (nAMD) Over 2 Years With a Treat and Extend (T&E) Regimen of 2 mg Intravitreal Aflibercept - a Randomized, Open-label, Active-controlled, Parallel-group Phase IV/IIIb Study (ARIES)
This study aims to evaluate the optimal use, efficacy, and safety of a Treat-and-Extend regimen with aflibercept in subjects with nAMD.
The T\&E dosing regimen for nAMD has emerged as a preferred regimen for many treating physicians aiming at maximizing outcomes by proactively treating the subject at each visit and by extending the treatment interval (if extension criteria are met), thus limiting visits, monitoring, and injections. To this day, there is limited evidence available addressing the question of what are useful intervals for treating and monitoring, how do they differ among subjects, and how are retreatment criteria applied to achieve long-term desirable outcomes in real-life practice. This study is designed to evaluate the optimal use, efficacy, and safety of the T\&E regimen with intravitreal aflibercept in subjects with nAMD.
Age
50 - No limit years
Sex
ALL
Healthy Volunteers
No
Strathfield, New South Wales, Australia
Sydney, New South Wales, Australia
Westmead, New South Wales, Australia
East Melbourne, Victoria, Australia
Launceston, Australia
Hamilton, Ontario, Canada
Ottawa, Ontario, Canada
Boisbriand, Quebec, Canada
Créteil, France
Nice, France
Start Date
November 19, 2015
Primary Completion Date
April 26, 2019
Completion Date
April 26, 2019
Last Updated
November 8, 2023
287
ACTUAL participants
Eylea (Intravitreal Aflibercept, VEGF Trap-Eye, BAY86-5321)
DRUG
Eylea (Intravitreal Aflibercept, VEGF Trap-Eye, BAY86-5321)
DRUG
Lead Sponsor
Bayer
Collaborators
NCT05913063
NCT07446582
NCT06779773
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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