Evidence map›Paper›PMID 38114333›Full record

Trial reportBMJ open ophthalmology2023

Biosimilar SB15 versus reference aflibercept in neovascular age-related macular degeneration: 1-year and switching results of a phase 3 clinical trial.

SriniVas R Sadda, Mario Bradvica, Attila Vajas, Min Sagong, Jan Ernest, Jan Studnička, Miroslav Veith, Edward Wylegala, Sunil Patel, Cheolmin Yun and 9 more

Open access · goldAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in BMJ open ophthalmology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 3 pooled it
4.2field-weighted citation impact, top 5% 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

13 citing papers in PubMed, 3 syntheses or guidelines pooled it, 15 citations in OpenAlex.

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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

19 authors at 15 institutions in 7 countries.

SriniVas R SaddaDepartment of Ophthalmology, Doheny Eye Institute, Pasedena, California, USA.ORCID 0000-0002-4939-3306
Mario BradvicaMedical Faculty, Univesity Josip Juraj Strossmayer, Osijek, Croatia.
Attila VajasDepartment of Ophthalmology, University of Debrecen, Debrecen, Hungary.
Min SagongDepartment of Ophthalmology, Yeungnam University School of Medicine and College of Medicine, Daegu, Korea.
Jan ErnestDepartment of Ophthalmology, Axon Clinical, Praha, Czech Republic.
Jan StudničkaOphthalmology, University Hospital, Hradec Králové, Czech Republic.
Miroslav VeithDepartment of Ophthalmology, University Hospital Kralovske Vinohrady, Prague, Czech Republic.
Edward WylegalaOphthalmology Department, Medical University of Silesia, Katowice, Poland.ORCID 0000-0002-5919-3789
Sunil PatelRetina Research Institute, Abilene, Texas, USA.
Cheolmin YunOphthalmology, Korea University Ansan Hospital, Ansan, Gyeonggi-do, Korea.
Michal OrskiOphthalmology, Rydygier Memorial Hospital, Krakow, Poland.ORCID 0000-0002-9306-1405
Sergei AstakhovFirst Pavlov State Medical University, St.Petersburg, Russian Federation.
Edit Tóth-MolnárDepartment of Ophthalmology, University of Szeged, Szeged, Hungary.
Adrienne CsutakDepartment of Ophthalmology, Pécs University Medical School, Pécs, Hungary.
Lajos EnyediBajcsy-Zsilinszky Korhaz es Rendelointezet, Budapest, Hungary.
Wooree ChoiSamsung Bioepis Co., Ltd, Incheon, Korea.
Inkyung OhSamsung Bioepis Co., Ltd, Incheon, Korea.
Hyerin JangSamsung Bioepis Co., Ltd, Incheon, Korea.
Se Joon WooOphthalmology, Seoul National University Bundang Hospital, Seongnam, Korea sejoon1@snu.ac.kr.ORCID 0000-0003-3692-7169
Samsung (South Korea) · KRBajcsy-Zsilinszky Kórház és Rendelőintézet · HUCharles University · CZFirst Pavlov State Medical University of St. Petersburg · RUKorea University · KRMedical University of Silesia · PLRetina Research Institute of Texas · USSeoul National University Bundang Hospital · KRUniversity Hospital Hradec Králové · CZUniversity of California, Los Angeles · USUniversity of Debrecen · HUUniversity of Osijek · HRUniversity of Pecs · HUUniversity of Szeged · HUYeungnam University · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND/

aimsTo evaluate efficacy, safety, pharmacokinetics (PK) and immunogenicity of SB15 versus reference aflibercept (AFL), and switching from AFL to SB15 in neovascular age-related macular degeneration (nAMD).

designProspective, double-masked, randomised, phase 3 trial.

methodsParticipants with nAMD were randomised 1:1 to receive SB15 (N=224 participants) or AFL (N=225). At week 32, participants either continued on SB15 (SB15/SB15, N=219) or AFL (AFL/AFL, N=108), or switched from AFL to SB15 (AFL/SB15, N=111). This manuscript reports 1-year and switching results of secondary efficacy endpoints such as changes from baseline to week 56 in best-corrected visual acuity (BCVA), central subfield thickness (CST, from internal limiting membrane (ILM) to retinal pigment epithelium), and total retinal thickness (TRT, from ILM to Bruch's membrane). Additional endpoints included safety, PK and immunogenicity.

resultsEfficacy results were comparable between groups. The least squares mean (LSmean) change in BCVA from baseline to week 56 was 7.4 letters for SB15/SB15 and 7.0 letters for AFL/AFL (difference (95% CI)=0.4 (-2.5 to 3.2)). The LSmean changes from baseline to week 56 in CST and TRT were -119.2 µm and -132.4 µm for SB15/SB15 and -126.6 µm and -136.3 µm for AFL/AFL, respectively (CST: difference (95% CI)=7.4 µm (-6.11 to 20.96); TRT: difference (95% CI)=3.9 µm (-18.35 to 26.10)). Switched and non-switched participants showed similar LSmean changes in BCVA from baseline to week 56 (AFL/SB15, 7.9 letters vs AFL/AFL, 7.8 letters; difference (95% CI)=0.0 (-2.8 to 2.8)). Safety, PK and immunogenicity were comparable between groups.

conclusionsEfficacy, safety, PK and immunogenicity were comparable between SB15 and AFL and between switched and non-switched participants.

Indexed as

Biosimilar PharmaceuticalsMacular DegenerationAngiogenesis InhibitorsHumansIntravitreal InjectionsProspective StudiesReceptors, Vascular Endothelial Growth FactorRecombinant Fusion ProteinsVisual AcuityafliberceptAngiogenesis InhibitorsBiosimilar PharmaceuticalsReceptors, Vascular Endothelial Growth FactorRecombinant Fusion Proteinsclinical trialdegenerationmaculaneovascularisation

Identifiers

PMID38114333
OpenAlexW4389966332

What OpenQuestion 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 OpenQuestion graph.