drugset / Trial / 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)

NCT06491914

Phase 3 Active not recruiting 1118 enrolled Regeneron Pharmaceuticals
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2024-07-24
Primary completion
2025-08-26
Completion
2027-01-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Aflibercept Protein / enzyme biologic 8 mg Intravitreal