Evidence map›Paper›PMID 39367347›Full record

ArticleBMC ophthalmology2024

Efficacy and safety of treat-and-extend intravitreal brolucizumab in naive and switched patients with macular neovascularization: one-year follow-up study.

Francesco Faraldi, Carlo Alessandro Lavia, Marco Nassisi, Raphael Kilian, Clara Rizzo, Maria Cristina Savastano, Stanislao Rizzo, Fabrizio Giansanti, Daniela Bacherini

Abstract read
In one paragraph

Article in BMC ophthalmology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
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.

Francesco FaraldiOphthalmology Unit, Surgical Department, A.O. Ordine Mauriziano, Turin, Italy.
Carlo Alessandro LaviaOphthalmology Unit, Surgical Department, A.O. Ordine Mauriziano, Turin, Italy. carlo.lavia@gmail.com.
Marco NassisiDepartment of Clinical Sciences and Community Health, University of Milan, Milan, Italy.
Raphael KilianOphthalmic Unit, Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Verona, Italy.
Clara RizzoOphthalmic Unit, Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Verona, Italy.
Maria Cristina SavastanoOphthalmology Unit, Fondazione Policlinico A. Gemelli IRCCS, Rome, Italy.
Stanislao RizzoOphthalmology Unit, Fondazione Policlinico A. Gemelli IRCCS, Rome, Italy.
Fabrizio GiansantiNeuromuscular and Sense Organs Department, Eye Clinic, Careggi University Hospital, Florence, Italy.
Daniela BacheriniNeuromuscular and Sense Organs Department, Eye Clinic, Careggi University Hospital, Florence, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundto analyze, at one year, the efficacy and safety of treat-and-extend (T&E) intravitreal (IV) Brolucizumab in patients affected by macular neovascularization (MNV). Both naïve and previously treated (i.e., switched) patients were included, and the data from the two groups were compared.

methodsanatomical (i.e., central subfoveal thickness, CST; presence of fluid), functional (i.e., best corrected visual acuity, BCVA) and treatment-related (i.e., number of IV injections within the study period; number of patients reaching a 12-weeks interval between treatments) data from 41 eyes of 41 subjects (20 naïve and 21 switched) were analyzed. Patients were treated with 3 monthly IV injections followed by a T&E regimen based on a disease activity assessment performed at each scheduled IV treatment.

resultssignificant CST reduction (from 412.1 ± 115.8 to 273.2 ± 61.6; p < 0.05) and BCVA (mean; p) improvement were observed in the naïve group, while in the switched cohort, both parameters were almost stable. In the naïve and switched groups, 55% and 33.5% of patients, respectively, reached a 12-week IV interval at one year, with a mean of 6.55 ± 1 and 7.43 ± 0.68 IV treatments, respectively. One patient with mild anterior uveitis without sequelae was recorded.

conclusionIn patients with MNV, IV Brolucizumab injections following a T&E regimen demonstrated great efficacy and a good safety profile, with greater anatomical and functional results in naïve patients.

trial registrationThis study was approved by the Local Ethics Committee (protocol number 155/2020, general registry number n°11486, InterHospital Ethics Committee, San Luigi Gonzaga Hospital, Orbassano, Italy).

Indexed as

Angiogenesis InhibitorsAntibodies, Monoclonal, HumanizedIntravitreal InjectionsTomography, Optical CoherenceVisual AcuityAgedAged, 80 and overDrug SubstitutionFemaleFollow-Up StudiesHumansMacula LuteaMaleMiddle AgedRetinal NeovascularizationRetrospective StudiesAngiogenesis InhibitorsAntibodies, Monoclonal, HumanizedbrolucizumabVascular Endothelial Growth Factor ABrolucizumab safetyIntravitreal BrolucizumabIntravitreal injection intervalMacular neovascularizationNaïve patientsOCTSwitched patientsTreat and extend

Identifiers

PMID39367347
PMCPMC11452950

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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 OpenQuestion graph.