Evidence map›Paper›PMID 40397174›Full record

ArticleDie Ophthalmologie2025

[Faricimab in previously treated neovascular age-related macular degeneration : Study design of the prospective noninterventional study PASSENGER].

Britta Heimes-Bussmann, Rooschanak Bellenbaum, Christian Njoo, Sandra Liakopoulos, Steffen Schmitz-Valckenberg, Max Zortel, Kai Rothaus, Jost Leemhuis, Peter Mussinghoff, Albrecht Lommatzsch

Abstract readMulticenter StudyEnglish Abstract
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In one paragraph

Article in Die Ophthalmologie, 2025. 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

10 authors.

Britta Heimes-BussmannAugenzentrum am St. Franziskus-Hospital Münster, Hohenzollernring 74, 48145, Münster, Deutschland.
Rooschanak BellenbaumRoche Pharma AG, Grenzach-Wyhlen, Deutschland.
Christian NjooRoche Pharma AG, Grenzach-Wyhlen, Deutschland.
Sandra LiakopoulosCologne Image Reading Center (CIRCL), Universitätsklinikum Köln, Köln, Deutschland.
Steffen Schmitz-ValckenbergGrade Reading Center Bonn, UKB Universitätsklinikum Bonn, Bonn, Deutschland.
Max ZortelRoche Pharma AG, Grenzach-Wyhlen, Deutschland.
Kai RothausAugenzentrum am St. Franziskus-Hospital Münster, Hohenzollernring 74, 48145, Münster, Deutschland.
Jost LeemhuisRoche Pharma AG, Grenzach-Wyhlen, Deutschland.
Peter MussinghoffAugenzentrum am St. Franziskus-Hospital Münster, Hohenzollernring 74, 48145, Münster, Deutschland.
Albrecht LommatzschAugenzentrum am St. Franziskus-Hospital Münster, Hohenzollernring 74, 48145, Münster, Deutschland. albrecht.lommatzsch@augen-franziskus.de.ORCID http://orcid.org/0000-0001-9640-4103

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundFaricimab was approved in the European Union in 9/2022 as the first bispecific antibody for the treatment of neovascular age-related macular degeneration (nAMD), visual impairment due to diabetic macular oedema (DME) or retinal vein occlusion. To date, the efficacy profile of faricimab has been investigated under pivotal clinical phase 3 study conditions in treatment-naïve nAMD patients. The prospective noninterventional study (NIS) PASSENGER is a multicentre study that aims at contributing to a better understanding of the effectiveness, safety and impact of faricimab on quality of life in previously treated patients with nAMD under real-world conditions in Germany.

methodsThe planned observation period per patient is 24 months. Patients (n = 620) aged ≥ 50 years with nAMD who switched to faricimab no longer than 12 weeks prior to enrolment in the study, were previously treated with a vascular endothelial growth factor (VEGF) inhibitor for a maximum of 36 months, and had a best corrected visual acuity (BCVA) of 30-80 letters on the Early Treatment Diabetic Retinopathy Study (ETDRS) scale at the start of therapy with faricimab are eligible to participate. The primary outcome measure is the change in BCVA from baseline after 52 weeks. In addition, central subfield thickness, intraretinal, subretinal and subpigment epithelial fluid over time as well as patient-reported outcomes, adherence and adverse events are recorded.

resultThe first patient was enrolled in June 2023. According to the current schedule, recruitment (24 months) will be completed by June 2025 and the last patient visit is anticipated in Q2/2027.

conclusionData from the PASSENGER study are intended to contribute to a better understanding of therapy management in daily practice in Germany.

Indexed as

Wet Macular DegenerationAgedAngiogenesis InhibitorsAntibodies, BispecificFemaleGermanyHumansIntravitreal InjectionsMaleMiddle AgedProspective StudiesQuality of LifeTreatment OutcomeVisual AcuityAngiogenesis InhibitorsAntibodies, BispecificfaricimabBispecific antibodyFaricimabnAMDNeovascular age-related macular degenerationNon-interventional studyReal-world evidenceStudy design

Identifiers

What Socratic holds

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Registered trials

None linked

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.