NCT07074054

Aflibercept 8 mg for nAMD: Early Anatomical and Functional Changes

Early Anatomical and Functional Changes With Aflibercept 8 mg in Neovascular Age-Related Macular Degeneration: A Prospective Case Series

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 40 (actual)
• Sponsor: Federico II University · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

Neovascular age-related macular degeneration (nAMD) is one of the main causes of irreversible vision loss in older people worldwide. the central role of vascular endothelial growth factor (VEFG) in the pathogenesis of nAMD has been extensively demonstrated. Since its introduction, intravitreal injection of targeted anti-VEGF antibodies has become the first-line treatment. Aflibercept 8 mg is a new formulation whose efficacy and safety as a new nAMD treatment has been demonstrated in the PULSAR study, emphasising its potential role in reducing the treatment burden in relation to the intended dosing intervals. The aim of this study is to investigate early anatomical and functional changes in naïve nAMD patients treated with 8 mg aflibercept compared to patients treated with 2 mg aflibercept using OCT and MPOD, as potential parameters for functional outcome. To our knowledge, this is the first study to investigate these changes and the efficacy of aflibercept 8 mg as a potential fast-drying anti-VEGF treatment.

Conditions

• Presence of Retinal Fluid
• Changes in Macular Pigment Optical Density

Timeline

• Start date: 2024-04-15
• Primary completion: 2024-04-15
• Completion: 2025-03-30
• First posted: 2025-07-20
• Last updated: 2025-07-20

Locations

1 site across 1 country: Italy