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Impact of Baseline Retinal Nonperfusion and Macular Retinal Capillary Nonperfusion on Outcomes in the COPERNICUS and GALILEO Studies

dc.rights.licenseopenen_US
dc.contributor.authorFELTGEN, N.
dc.contributor.authorOGURA, Y.
dc.contributor.authorBOSCIA, F.
dc.contributor.authorHOLZ, F. G.
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorKOROBELNIK, Jean-Francois
ORCID: 0000-0002-4438-9535
IDREF: 028739272
dc.contributor.authorBROWN, D. M.
dc.contributor.authorHEIER, J. S.
dc.contributor.authorSTEMPER, B.
dc.contributor.authorRITTENHOUSE, K. D.
dc.contributor.authorASMUS, F.
dc.contributor.authorAHLERS, C.
dc.contributor.authorVITTI, R.
dc.contributor.authorSAROJ, N.
dc.contributor.authorMITCHELL, P.
dc.date.accessioned2020-06-12T08:40:19Z
dc.date.available2020-06-12T08:40:19Z
dc.date.issued2019-07
dc.identifier.issn2468-6530en_US
dc.identifier.urihttps://oskar-bordeaux.fr/handle/20.500.12278/7902
dc.description.abstractEnPURPOSE: To evaluate the impact of baseline retinal capillary nonperfusion (RNP) and macular retinal capillary nonperfusion (MNP) status on outcomes at week 24 (W24). DESIGN: Post hoc analyses of 2 phase 3, randomized, double-masked, multicenter, sham-controlled studies. PARTICIPANTS: Three hundred sixty-six patients with macular edema secondary to central retinal vein occlusion randomized in COPERNICUS and GALILEO. METHODS: We randomized patients 3:2 to receive intravitreal aflibercept 2 mg every 4 weeks or sham injections until W24. RNP and MNP were assessed by a masked independent reading center. MAIN OUTCOME MEASURES: Proportion of patients with 10 disc areas (DA) or more of RNP and any degree of MNP at W24, relative risks of 10 DA or more of RNP or any degree of MNP at W24 developing, change from baseline in best-corrected visual acuity (BCVA) and central retinal thickness (CRT) by baseline RNP and MNP status, and relationship between baseline RNP and MNP status. RESULTS: At baseline, 24.6% of patients showed 10 DA or more of RNP and 72.6% showed MNP, regardless of baseline RNP status. At W24, the pooled proportions of patients in the intravitreal aflibercept and sham groups with 10 DA or more of RNP were 11.6% and 29.0%, respectively (P = 0.0001); the respective proportions with any degree of MNP were 61.2% and 79.5% (P = 0.0008). Relative risks and 95% confidence intervals for intravitreal aflibercept versus sham were 0.4 (0.25-0.62) for 10 DA or more of RNP and 0.8 (0.68-0.90) for MNP, indicating a lower risk for these outcomes with intravitreal aflibercept than with sham. Mean BCVA change was greater in intravitreal aflibercept- versus sham-treated eyes, with less than 10 DA and 10 DA or more of RNP at baseline (+17.5 vs. +0.8 letters and +18.3 vs. -4.1 letters, respectively) and with and without baseline MNP (+15.7 vs. +0.3 letters and +17.1 vs. +0.4 letters, respectively). Agreement between baseline RNP and MNP status was low (kappa = 0.12). The proportions of patients with 1 or more ocular serious adverse event in the intravitreal aflibercept- and sham-treated groups, respectively, were 3.2% and 11.3%. CONCLUSIONS: At W24, visual and anatomic improvements, including perfusion status, were greater in eyes treated with intravitreal aflibercept than in eyes treated with sham, regardless of baseline RNP or MNP status.
dc.language.isoENen_US
dc.rightsAttribution-NonCommercial-NoDerivs 3.0 United States*
dc.rights.urihttp://creativecommons.org/licenses/by-nc-nd/3.0/us/*
dc.subject.enLEHA
dc.title.enImpact of Baseline Retinal Nonperfusion and Macular Retinal Capillary Nonperfusion on Outcomes in the COPERNICUS and GALILEO Studies
dc.title.alternativeOphthalmol Retinaen_US
dc.typeArticle de revueen_US
dc.identifier.doi10.1016/j.oret.2019.02.010en_US
dc.subject.halSciences du Vivant [q-bio]/Santé publique et épidémiologieen_US
dc.identifier.pubmed31277796en_US
bordeaux.journalOphthalmology Retinaen_US
bordeaux.page553-560en_US
bordeaux.volume3en_US
bordeaux.hal.laboratoriesBordeaux Population Health Research Center (BPH) - U1219en_US
bordeaux.issue7en_US
bordeaux.institutionUniversité de Bordeauxen_US
bordeaux.teamLEHA_BPH
bordeaux.peerReviewedouien_US
bordeaux.inpressnonen_US
hal.identifierhal-03209877
hal.version1
hal.date.transferred2021-04-27T13:09:25Z
hal.exporttrue
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