NCT02581891

Managing Neovascular (Known as "Wet") Age-related Macular Degeneration Over 2 Years Using Different Treatment Schedules of 2 mg Intravitreal Aflibercept Injected in the Eye

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)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 287 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

This study aims to evaluate the optimal use, efficacy, and safety of a Treat-and-Extend regimen with aflibercept in subjects with nAMD.

Detailed description

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.

Conditions

• Macular Degeneration

Interventions

Type	Name	Description
DRUG	Eylea (Intravitreal Aflibercept, VEGF Trap-Eye, BAY86-5321)	3 monthly doses followed by individualized treatment intervals of between 8 to16 weeks based on protocol-defined anatomical criteria
DRUG	Eylea (Intravitreal Aflibercept, VEGF Trap-Eye, BAY86-5321)	3 monthly doses followed by five 8-weekly doses (5 x 2Q8), then by individualized treatment intervals of between 8 to 16 weeks based on protocol-defined anatomical criteria

Timeline

• Start date: 2015-11-19
• Primary completion: 2019-04-26
• Completion: 2019-04-26
• First posted: 2015-10-21
• Last updated: 2023-11-08
• Results posted: 2020-05-21

Locations

39 sites across 8 countries: Australia, Canada, France, Germany, Hungary, Italy, Spain, United Kingdom

Regulatory

• FDA-regulated drug study