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Intravitreal aflibercept 8 mg in neovascular age-related macular degeneration (PULSAR): 48-week results from a randomised, double-masked, non-inferiority, phase 3 trial

dc.rights.licenseopenen_US
dc.contributor.authorLANZETTA, Paolo
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorKOROBELNIK, Jean-Francois
dc.contributor.authorHEIER, Jeffrey S
dc.contributor.authorLEAL, Sergio
dc.contributor.authorHOLZ, Frank G
dc.contributor.authorCLARK, W Lloyd
dc.contributor.authorEICHENBAUM, David
dc.contributor.authorIIDA, Tomohiro
dc.contributor.authorXIAODONG, Sun
dc.contributor.authorBERLINER, Alyson J
dc.contributor.authorSCHULZE, Andrea
dc.contributor.authorSCHMELTER, Thomas
dc.contributor.authorSCHMIDT-OTT, Ursula
dc.contributor.authorZHANG, Xin
dc.contributor.authorVITTI, Robert
dc.contributor.authorCHU, Karen W
dc.contributor.authorREED, Kimberly
dc.contributor.authorRAO, Rohini
dc.contributor.authorBHORE, Rafia
dc.contributor.authorCHENG, Yenchieh
dc.contributor.authorSUN, Wei
dc.contributor.authorHIRSHBERG, Boaz
dc.contributor.authorYANCOPOULOS, George D
dc.contributor.authorWONG, Tien Y
dc.contributor.authorINVESTIGATORS, Pulsar
dc.date.accessioned2024-05-06T12:12:33Z
dc.date.available2024-05-06T12:12:33Z
dc.date.issued2024-03-07
dc.identifier.issn1474-547Xen_US
dc.identifier.urihttps://oskar-bordeaux.fr/handle/20.500.12278/199660
dc.description.abstractEnBACKGROUND: Intravitreal aflibercept 8 mg could improve treatment outcomes and provide sustained disease control in patients with neovascular age-related macular degeneration (nAMD), with extended dosing compared with aflibercept 2 mg. METHODS: PULSAR is a phase 3, randomised, three-group, double-masked, non-inferiority, 96-week trial conducted across 223 sites worldwide. Adults with nAMD were randomised 1:1:1 to aflibercept 8 mg every 12 weeks (8q12), aflibercept 8 mg every 16 weeks (8q16), or aflibercept 2 mg every 8 weeks (2q8), following three initial monthly doses in all groups. From week 16, patients in the aflibercept 8 mg groups had their dosing interval shortened if pre-specified dose regimen modification criteria denoting disease activity were met. The primary endpoint was change from baseline in best-corrected visual acuity (BCVA) at week 48. All patients with at least one dose of study treatment were included in the efficacy and safety analyses. This trial is registered with ClinicalTrials.gov (NCT04423718) and is ongoing. FINDINGS: Of 1011 patients randomised to aflibercept 8q12 (n=336), 8q16 (n=338), or 2q8 (n=337) between Aug 11, 2020, and July 30, 2021, 1009 patients received study treatment (aflibercept 8q12 n=335; aflibercept 8q16 n=338; and aflibercept 2q8 n=336). Aflibercept 8q12 and 8q16 showed non-inferior BCVA gains versus aflibercept 2q8 (mean BCVA change from baseline +6·7 [SD 12·6] and +6·2 [11·7] vs +7·6 [12·2] letters). The least squares mean differences between aflibercept 8q12 versus 2q8 and 8q16 versus 2q8, respectively, were -0·97 (95% CI -2·87 to 0·92) and -1·14 (-2·97 to 0·69) letters (non-inferiority margin at 4 letters). The incidence of ocular adverse events in the study eye was similar across groups (aflibercept 8q12 n=129 [39%]; aflibercept 8q16 n=127 [38%]; and aflibercept 2q8 n=130 [39%]). INTERPRETATION: Aflibercept 8 mg showed efficacy and safety with extended dosing intervals, which has the potential to improve the management of patients with nAMD. FUNDING: Bayer AG and Regeneron Pharmaceuticals.
dc.language.isoENen_US
dc.title.enIntravitreal aflibercept 8 mg in neovascular age-related macular degeneration (PULSAR): 48-week results from a randomised, double-masked, non-inferiority, phase 3 trial
dc.title.alternativeLanceten_US
dc.typeArticle de revueen_US
dc.identifier.doi10.1016/s0140-6736(24)00063-1en_US
dc.subject.halSciences du Vivant [q-bio]/Santé publique et épidémiologieen_US
dc.identifier.pubmed38461841en_US
bordeaux.journalThe Lanceten_US
bordeaux.page1141-1152en_US
bordeaux.volume403en_US
bordeaux.hal.laboratoriesBordeaux Population Health Research Center (BPH) - UMR 1219en_US
bordeaux.issue10432en_US
bordeaux.institutionUniversité de Bordeauxen_US
bordeaux.institutionINSERMen_US
bordeaux.teamLEHA_BPHen_US
bordeaux.peerReviewedouien_US
bordeaux.inpressnonen_US
bordeaux.identifier.funderIDBayeren_US
bordeaux.identifier.funderIDRegeneron Pharmaceuticalsen_US
hal.identifierhal-04569569
hal.version1
hal.date.transferred2024-05-06T12:12:38Z
hal.popularnonen_US
hal.audienceInternationaleen_US
hal.exporttrue
dc.rights.ccPas de Licence CCen_US
bordeaux.COinSctx_ver=Z39.88-2004&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.jtitle=The%20Lancet&rft.date=2024-03-07&rft.volume=403&rft.issue=10432&rft.spage=1141-1152&rft.epage=1141-1152&rft.eissn=1474-547X&rft.issn=1474-547X&rft.au=LANZETTA,%20Paolo&KOROBELNIK,%20Jean-Francois&HEIER,%20Jeffrey%20S&LEAL,%20Sergio&HOLZ,%20Frank%20G&rft.genre=article


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