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NCT07074054
Aflibercept 8 mg for nAMD: Early Anatomical and Functional Changes
trial in Presence of Retinal Fluid in 40 participants. Completed in 30 March 2025.
15 April 2024
Quick facts
| Lead sponsor | Federico II University |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 40 |
| Start date | 15 April 2024 |
| Primary completion | 15 April 2024 |
| Estimated completion | 30 March 2025 |
| Sites | 1 location across Italy |
Conditions studied
- Presence of Retinal Fluid — all drugs for Presence of Retinal Fluid →
- Changes in Macular Pigment Optical Density — all drugs for Changes in Macular Pigment Optical Density →
Sponsor
Federico II University
Who can join
50 and older, any sex, with Presence of Retinal Fluid or Changes in Macular Pigment Optical Density. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Aflibercept 8 mg in Neovascular AMD-A Fast-Drying Anti-VEGF Drug: A Prospective Morpho-Functional Pilot Study.
Rinaldi M, Cennamo G, Concilio M, Corvino G, et al · · 2026 · PMID 41388185 · DOI 10.1007/s40123-025-01296-8
Verify or expand the search:
- PubMed search for NCT07074054
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07074054 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Federico II University
- Last refreshed: 20 July 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07074054.
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