Evidence map›Paper›PMID 40833455›Full record

ArticleOphthalmology and therapy2025

Multimodal Imaging to Assess Disease Activity and Predict Fluid Resolution in Patients with wAMD Treated with Brolucizumab: The IMAGINE Study.

Marco Lupidi, Francesco Bandello, Stela Vujosevic, Mariacristina Parravano, Daniela Bacherini, Angelo Maria Minnella, Fabrizio Giansanti, Chiara Ascardi, Giovanni Staurenghi

Registry-linked trialAbstract read
In one paragraph

Article in Ophthalmology and therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04774926 (One Year, Single Arm, Open Label, Multicenter, Phase IV Study Using Multimodal Imaging to Guide Disease Activity Assessment Through Innovative Early Predictive Anatomical Biomarkers of Fluid Resolution in wAMD Patients Treated With Brolucizumab- IMAGINE Study), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04774926 phase4completednot on this map

One Year, Single Arm, Open Label, Multicenter, Phase IV Study Using Multimodal Imaging to Guide Disease Activity Assessment Through Innovative Early Predictive Anatomical Biomarkers of Fluid Resolution in wAMD Patients Treated With Brolucizumab- IMAGINE Study

TypeinterventionalSponsorNovartis PharmaceuticalsRan2021 to 2023Enrolled122ConditionsNeovascular Age-related Macular DegenerationArmsBrolucizumab
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Marco LupidiEye Clinic, Department of Experimental and Clinical Medicine, Polytechnic University of Marche, Ancona, Italy. marcomed2@gmail.com.ORCID http://orcid.org/0000-0002-6817-2488
Francesco BandelloDepartment of Ophthalmology, University Vita-Salute, Scientific Institute San Raffaele, Milan, Italy.
Stela VujosevicDepartment of Biomedical, Surgical and Dental Sciences, University of Milan, Milan, Italy.
Mariacristina ParravanoIRCCS Fondazione G.B. Bietti, Rome, Italy.
Daniela BacheriniDepartment of Neurosciences, Psycopathology, Drug Research and Child Health, Eye Clinic, University of Florence, AOU Careggi, Florence, Italy.
Angelo Maria MinnellaInstitute of Ophthalmology, Università Cattolica del Sacro Cuore, Rome, Italy.
Fabrizio GiansantiDepartment of Neurosciences, Psycopathology, Drug Research and Child Health, Eye Clinic, University of Florence, AOU Careggi, Florence, Italy.
Chiara AscardiNovartis Farma S.P.A, Milan, Italy.
Giovanni StaurenghiDepartment of Biomedical and Clinical Sciences, Eye Clinic, University of Milan, Milan, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThis prospective, open-label, single-arm, multicenter phase IV study (NCT04774926) evaluated early imaging parameters as predictors of long-term fluid resolution and assessed the efficacy and safety of brolucizumab in treatment-naïve patients with wet age-related macular degeneration (wAMD) in a real-world Italian setting. PATIENTS AND

methodsA total of 122 patients aged ≥ 50 years with subfoveal macular neovascularization secondary to wAMD were enrolled. All patients were anti-vascular endothelial growth factor (anti-VEGF)- and investigational treatment-naïve. Brolucizumab (6 mg) was administered intravitreally at baseline and weeks 4 and 8, followed by maintenance dosing every 12 weeks (q12w) or 8 weeks, on the basis of disease activity. Imaging modalities included spectral-domain optical coherence tomography (OCT), OCT angiography, fluorescein angiography, and indocyanine green angiography. Disease activity was assessed using anatomical and functional parameters.

resultsNo significant predictive anatomical biomarkers for fluid-free status were identified. At week 48, 22.5% of patients achieved q12w fluid-free status. Significant reductions in central subfield thickness were observed, with a median change of -143.0 µm (p < 0.0001). Median best-corrected visual acuity improved by 5.5 Early Treatment Diabetic Retinopathy Study (ETDRS) letters from baseline (p < 0.0001). Ocular adverse events were consistent with the known safety profile of brolucizumab.

conclusionsBrolucizumab demonstrated effectiveness and safety in a real-world wAMD cohort, aligning with findings from randomized trials. Although no predictive biomarkers were identified, results emphasize the role of multimodal imaging in guiding individualized treatment strategies and highlight variability in patient responses. CLINICALTRIALS: GOV ID: NCT04774926.

Indexed as

Age-related macular degenerationBrolucizumabMultimodal imagingPredictive anatomical biomarkersReal-world studyWet AMD

Identifiers

PMID40833455
PMCPMC12413378

What Socratic holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.