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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07074054

Enrollment

Registered

2025-07-20

Start date

2024-04-15

Completion date

2025-03-30

Last updated

2025-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Changes in Macular Pigment Optical Density, Presence of Retinal Fluid

Keywords

nAMD, OCT, MPOD

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Italy

Outcome results