NCT02305238

Japanese Treat and Extend Study of Aflibercept in Neovascular Age-related Macular Degeneration

A Randomized, Open-label Phase 4 Study Evaluating the Efficacy and Safety of Repeated Doses of Intravitreal Aflibercept With Variable Treatment Intervals in Japanese Subjects With Neovascular Age-related Macular Degeneration

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 288 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

To assess the efficacy of intravitreal (IVT) administration of aflibercept with two different approaches of Treat and Extend dosing regimens in Japanese subjects with neovascular (wet) Age-related Macular Degeneration (wAMD) . To assess the safety of IVT administration of aflibercept with two different approaches of Treat and Extend dosing regimen in Japanese subjects with wAMD for up to 2 years.

Conditions

• Wet Macular Degeneration

Interventions

Type	Name	Description
DRUG	Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)	Aflibercept 2mg is intravitreally injected.

Timeline

• Start date: 2014-12-19
• Primary completion: 2016-12-22
• Completion: 2017-12-20
• First posted: 2014-12-02
• Last updated: 2023-11-18
• Results posted: 2018-03-12

Locations

41 sites across 1 country: Japan

Regulatory

• FDA-regulated drug study