NCT04423718

Study of the Effects of High Dose Aflibercept Injected Into the Eye of Patients With an Age-related Disorder That Causes Loss of Vision Due to Growth of Abnormal Blood Vessels at the Back of the Eye

Randomized, Double-Masked, Active-Controlled, Phase 3 Study of the Efficacy and Safety of High Dose Aflibercept in Patients With Neovascular Age-Related Macular Degeneration

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,011 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

In this study researchers want to learn more about changes in visual acuity (clarity of vision) with a high dose treatment with Aflibercept (Eylea) in patients suffering from neovascular age-related macular degeneration (nAMD). Neovascular AMD is an eye disease that causes blurred vision or a blind spot due to abnormal blood vessels that leak fluid or blood into the light sensitive lining inside the eye (retina). The fluid buildup causes the central part of the retina (macula) responsible for sharp, straight-ahead vision to swell and thicken (edema), which distorts vision.

Conditions

• Neovascular Age-Related Macular Degeneration

Interventions

Type	Name	Description
DRUG	Aflibercept High Dose VEGF Trap-Eye (BAY86-5321)	Solution in Vial, intravitreal (IVT) injection
DRUG	Aflibercept VEGF Trap-Eye (Eylea, BAY86-5321)	Solution in Vial, 2 mg, intravitreal (IVT) injection

Timeline

• Start date: 2020-08-11
• Primary completion: 2022-07-27
• Completion: 2024-08-07
• First posted: 2020-06-09
• Last updated: 2025-08-29
• Results posted: 2023-09-06

Locations

235 sites across 27 countries: United States, Argentina, Australia, Austria, Bulgaria, Canada, China, Czechia, Estonia, France, Georgia, Hungary, Israel, Italy, Japan, Latvia, Lithuania, Portugal, Russia, Serbia, Singapore, Slovakia, South Korea, Spain, Switzerland, Taiwan, Ukraine

Regulatory

• FDA-regulated drug study