University of Naples, Federico II
Naples, Napoli, Italy
Completed
NCT Number: NCT07074054
Aflibercept 8 mg for nAMD: Early Anatomical and Functional Changes
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.
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Notify MeKey information
Age range
50 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
MPOD and OCT after aflibercept 8 mg loading phase
Time frame: 7 months
The parameters analyzed by OCT and MPOD 4 months after the treatment are: OCT and MPOD.
Sponsors and collaborators
Lead sponsor
Federico II University
Other
Registry information
Official study title
Early Anatomical and Functional Changes With Aflibercept 8 mg in Neovascular Age-Related Macular Degeneration: A Prospective Case Series
Important dates
- Study start
- 2024
- Primary completion
- 2024
- Study completion
- 2025
- First posted
- Jul 20, 2025
- Registry last updated
- Jul 20, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.