Evidence map›Paper›PMID 39353678›Full record

Trial reportBMJ open ophthalmology2024

Baseline characteristics associated with the first year treatment interval of intravitreal faricimab in neovascular age-related macular degeneration (nAMD).

Parth Shah, Neala Rafijah, Yannan Tang, Sobha Sivaprasad, Thibaud Mathis, Philippe Margaron, Aachal Kotecha

Abstract readRandomized Controlled TrialClinical Trial, Phase IIIMulticenter Study
In one paragraph

Trial report in BMJ open ophthalmology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
–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

5 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Article
  4. Article
  5. 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

7 authors.

Parth ShahRoche Products Ltd, Welwyn Garden City, UK.
Neala RafijahPDC ION, Genentech Inc, South San Francisco, California, USA rafijahn@gene.com.ORCID 0009-0002-9267-2906
Yannan TangGenentech Inc, South San Francisco, California, USA.
Sobha SivaprasadNIHR Moorfields Biomedical Research Centre, London, UK.
Thibaud MathisOphthalmology, Croix Rousse University Hospital, Hospices Civils de Lyon, Lyon, France.
Philippe MargaronRoche Products Ltd, Welwyn Garden City, UK.
Aachal KotechaRoche Products Ltd, Welwyn Garden City, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsTo identify baseline characteristics that best correlate to treatment interval for naive neovascular age-related macular degeneration patients treated with faricimab in the first year (Y1) of the TENAYA and LUCERNE phase 3 trials, and to further understand how these characteristics may impact treatment intervals.

methodsThis post-hoc analysis of Y1 data from the TENAYA and LUCERNE trials evaluated ocular baseline characteristics associated with Y1 treatment intervals. Patients were categorised into three subgroups based on their Y1 treatment interval: Q16W, Q12W or Q8W. Baseline characteristics (central subfield thickness (CST), best-corrected visual acuity, presence of subretinal fluid in centre 1 mm, presence of retinal fluid in centre 1 mm, macular neovascularisation (MNV) location and MNV type) were inputted into an R package 'rpart' to create a classification tree model. A data-driven tree model based on CST was fitted, producing CST subgroups of low, middle and high ranges. Within each CST subgroup, the model identified the most impactful variables and associated thresholds.

resultsAfter fitting the data to produce data-driven CST ranges, the model chose MNV location, followed by MNV lesion type as the most impactful baseline characteristics with these factors having a p value <0.05 in a multivariate analysis.

conclusionsAmong the selected ocular baseline characteristics from TENAYA and LUCERNE trial, CST, MNV type and MNV location were seen as the most relevant variables to enable extension of treatment intervals during Y1. While this analysis provides insights for treatment intervals during the first year, further analysis incorporating Y2 data from the TENAYA and LUCERNE studies will be needed to assess factors influencing treatment intervals over a longer period.

Indexed as

Angiogenesis InhibitorsIntravitreal InjectionsVisual AcuityWet Macular DegenerationAgedAged, 80 and overDouble-Blind MethodFemaleHumansMaleTime FactorsTomography, Optical CoherenceTreatment OutcomeVascular Endothelial Growth Factor AAngiogenesis InhibitorsVascular Endothelial Growth Factor AVEGFA protein, humanMaculaNeovascularisationRetina

Identifiers

PMID39353678
PMCPMC11448128

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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.