Evidence map›Paper›PMID 35523860›Full record

Trial reportEye (London, England)2023

Therapeutic response in the HAWK and HARRIER trials using deep learning in retinal fluid volume and compartment analysis.

Ursula Schmidt-Erfurth, Zufar Mulyukov, Bianca S Gerendas, Gregor S Reiter, Daniel Lorand, Georges Weissgerber, Hrvoje Bogunović

Open access · hybridAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Eye (London, England), 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 31 papers.

0numbers the graph read from it
0cells of the map it votes in
31citing papers in PubMed
7.8field-weighted citation impact, top 1% of its field
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

31 citing papers in PubMed, 40 citations in OpenAlex.

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  3. A post-hoc analysis of intravitreal aflibercept-treated nAMD patients from ARIES & ALTAIR: predicting treatment intervals and frequency for aflibercept treat-and-extend therapy regimen using machine learning.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2025
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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 at 2 institutions in 2 countries.

Ursula Schmidt-ErfurthLaboratory for Ophthalmic Image Analysis, Department of Ophthalmology and Optometry, Medical University of Vienna, Vienna, Austria. ursula.schmidt-erfurth@meduniwien.ac.at.ORCID 0000-0002-7788-7311
Zufar MulyukovNovartis Pharma AG, Basel, Switzerland.
Bianca S GerendasLaboratory for Ophthalmic Image Analysis, Department of Ophthalmology and Optometry, Medical University of Vienna, Vienna, Austria.ORCID 0000-0001-8940-8130
Gregor S ReiterLaboratory for Ophthalmic Image Analysis, Department of Ophthalmology and Optometry, Medical University of Vienna, Vienna, Austria.ORCID 0000-0001-7661-4015
Daniel LorandNovartis Pharma AG, Basel, Switzerland.
Georges WeissgerberNovartis Pharma AG, Basel, Switzerland.
Hrvoje BogunovićLaboratory for Ophthalmic Image Analysis, Department of Ophthalmology and Optometry, Medical University of Vienna, Vienna, Austria.ORCID 0000-0002-9168-0894
Medical University of Vienna · ATNovartis (Switzerland) · CH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo assess the therapeutic response to brolucizumab and aflibercept by deep learning/OCT-based analysis of macular fluid volumes in neovascular age-related macular degeneration.

methodsIn this post-hoc analysis of two phase III, randomised, multi-centre studies (HAWK/HARRIER), 1078 and 739 treatment-naive eyes receiving brolucizumab or aflibercept according to protocol-specified criteria in HAWK and HARRIER, respectively, were included. Macular fluid on 41,840 OCT scans was localised and quantified using a validated deep learning-based algorithm. Volumes of intraretinal fluid (IRF), subretinal fluid (SRF), pigment epithelial detachment (PED) for all central macular areas (1, 3 and 6 mm) in nanolitres (nL) and best corrected visual acuity (BCVA) change in ETDRS letters were associated using mixed models for repeated measures.

resultsBaseline IRF volumes decreased by >92% following the first intravitreal injection and consistently remained low during follow-up. Baseline SRF volumes decreased by >74% following the first injection, while PED volume resolved by 68-79% of its baseline volume. Resolution of SRF and PED was dependent on the substance and regimen used. Larger residual post-loading IRF, SRF and PED volumes were all independently associated with progressive vision loss during maintenance, where the differences in mean BCVA change between high and low fluid volume subgroups for IRF, SRF and PED were 3.4 letters (p < 0.0001), 1.7 letters (p < 0.001) and 2.5 letters (p < 0.0001), respectively.

conclusionsDeep-learning methods allow an accurate assessment of substance and regimen efficacy. Irrespectively, all fluid compartments were found to be important markers of disease activity and were relevant for visual outcomes.

Indexed as

Deep LearningRetinal DetachmentWet Macular DegenerationAngiogenesis InhibitorsHumansIntravitreal InjectionsRanibizumabSubretinal FluidTomography, Optical CoherenceVascular Endothelial Growth Factor AAngiogenesis InhibitorsRanibizumabVascular Endothelial Growth Factor A

Identifiers

PMID35523860
PMCPMC10101971
OpenAlexW4229013494

What OpenQuestion holds

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LicenceCC BY
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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 OpenQuestion graph.