NCT06491914

A Phase 3b, Single-Arm Study of Aflibercept 8 mg Dosed Every 4 Weeks in Adult Participants With Neovascular Age-Related Macular Degeneration (nAMD) or Diabetic Macular Edema (DME)

A Phase 3b Single-Arm Study of Aflibercept 8 mg in Participants With Neovascular Age-Related Macular Degeneration (nAMD) or Diabetic Macular Edema (DME)

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,118 (actual)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is researching aflibercept high dose (HD), referred to as "study drug", with an experimental dosing regimen. The study is focused on participants with nAMD and DME that have been previously treated with anti-vascular endothelial growth factor (anti-VEGF) medications. The aim of the study is to see how safe and effective aflibercept HD injections are when given as frequently as every 4 weeks. The study is also looking at what side effects may happen from taking the study drug.

Conditions

• Neovascular Age-Related Macular Degeneration
• Diabetic Macular Edema

Interventions

Type	Name	Description
DRUG	Aflibercept 8 mg	Administered by intravitreal (IVT) injection

Timeline

• Start date: 2024-07-24
• Primary completion: 2025-08-26
• Completion: 2027-01-07
• First posted: 2024-07-09
• Last updated: 2025-10-15

Locations

54 sites across 2 countries: United States, Puerto Rico

Regulatory

• FDA-regulated drug study