Aflibercept 8 mg for nAMD: Early Anatomical and Functional Changes

Completed

• Conditions: Presence of Retinal Fluid; Changes in Macular Pigment Optical Density

• Registration Number: NCT07074054
• Lead Sponsor: Federico II University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-15
• Primary Completion: 2024-04-15
• Study Completion: 2025-03-30
• Study First Submitted: 2025-06-17
• Status Verified: 2025-07
• Study First Submitted QC: 2025-07-17
• Last Update Submitted: 2025-07-17
• Study First Posted: 2025-07-20
• Last Update Posted: 2025-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• age over 50 years; diagnosis of naïve nAMD due to the presence of active type 1 macular neovascularization (MNV)

Exclusion Criteria

• previous ocular surgery, history of vitreoretinal and/or retinal vascular diseases, uveitis, myopia over 6 dioptres, significant corneal and/or lens opacity, glaucoma, ocular MNV related to other causes than nAMD, geographic atrophy, subretinal fibrosis, previous treatments for MNV

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
MPOD and OCT after aflibercept 8 mg loading phase	7 months	The parameters analyzed by OCT and MPOD 4 months after the treatment are: OCT and MPOD.

Trial Locations

Locations (1)

University of Naples, Federico II; 🇮🇹 Napoli, Italy