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NCT07074054Completed

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

Source: ClinicalTrials.gov · Last updated 20 Jul 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Observational
Enrollment
40 (actual)
First submitted
17 Jun 2025
Start date
15 Apr 2024
Primary completion date
15 Apr 2024
Lead sponsor
Federico II University
NCT number
NCT07074054

What you commit to

  • Study type: Observational
  • Participants enrolled: 40
  • From 15 Apr 2024 to the primary completion date, 15 Apr 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

Who the study is looking for

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

Age in the registry: 50 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Naples Federico II
Coordinator of this site? Confirm its status
NaplesItalyUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.