Aflibercept 8 mg for nAMD: Early Anatomical and Functional Changes (NCT07074054) | Clinical Trial Compass
CompletedNot Applicable
Aflibercept 8 mg for nAMD: Early Anatomical and Functional Changes
Italy40 participantsStarted 2024-04-15
Plain-language 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.
Who can participate
Age range
50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.