Aflibercept 8 mg for nAMD: Early Anatomical and Functional Changes

Federico II University

Status: Completed

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

Study type: Observational

Funder types: Other

Identifiers

NCT07074054

05809857 Federico II

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 50+ years old

Volunteers: No 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

Trial design

40 participants in 2 patient groups

Study group

Description:

Patients with naive nAMD treated with aflibercept 8 mg

Control group

Description:

Patients with naive nAMD treated with aflibercept 2 mg