Efficacy and Safety of Intravitreal Aflibercept Treat-and-Extend for Macular Edema in Central Retinal Vein Occlusion: The CENTERA Study
| dc.rights.license | open | en_US |
| hal.structure.identifier | Bordeaux population health [BPH] | |
| dc.contributor.author | KOROBELNIK, Jean-Francois
ORCID: 0000-0002-4438-9535 IDREF: 028739272 | |
| dc.contributor.author | LARSEN, Michael | |
| dc.contributor.author | ETER, Nicole | |
| dc.contributor.author | BAILEY, Clare | |
| dc.contributor.author | WOLF, Sebastian | |
| dc.contributor.author | SCHMELTER, Thomas | |
| dc.contributor.author | ALLMEIER, Helmut | |
| dc.contributor.author | CHAUDHARY, Varun | |
| dc.date.accessioned | 2021-04-02T13:29:52Z | |
| dc.date.available | 2021-04-02T13:29:52Z | |
| dc.date.issued | 2021-02-06 | |
| dc.identifier.issn | 0002-9394 | en_US |
| dc.identifier.uri | https://oskar-bordeaux.fr/handle/20.500.12278/26867 | |
| dc.description.abstractEn | PURPOSE: To evaluate the efficacy and safety of intravitreal aflibercept (IVT-AFL) treat-and-extend (T&E) dosing in patients with macular edema secondary to central retinal vein occlusion (CRVO). DESIGN: CENTERA was an open-label, Phase 4 clinical study. METHODS: Patients received 2mg IVT-AFL at baseline and every 4 weeks (wks) until disease stability criteria were met (or until Wk20), at which point treatment intervals were adjusted in 2-wk increments based on functional and anatomic outcomes. RESULTS: From baseline to Wk76, 65.6% (n=105; P\textbackslashtextless0.0001 [test against threshold of 40%]) of patients gained ≥15 letters; and, during the T&E phase, 45.0% (n=72; P=0.8822 [test against threshold of 50%]) of patients achieved a mean treatment interval ≥8 wks. A last and next planned treatment interval of ≥8 wks was achieved by 63.1% (n=101) and 67.5% (n=108) of patients, respectively. Mean (standard deviation) best-corrected visual acuity increased from 51.9 (16.8) letters at baseline to 72.3 (18.5) letters at Wk76 (mean change: +20.3 [19.5] letters), and central retinal thickness decreased from 759.9 (246.0) µm at baseline to 265.4 (57.9) µm at Wk76 (mean change: -496.1 [252.4] µm). The safety profile of IVT-AFL was consistent with previous studies. CONCLUSIONS: Clinically meaningful improvements in functional and anatomic outcomes were achieved with IVT-AFL T&E dosing. Most patients achieved a last actual and last intended treatment interval of ≥8 wks, therefore treatment intervals may have been extended even further with a longer study duration. | |
| dc.language.iso | EN | en_US |
| dc.rights | Attribution-NonCommercial-NoDerivs 3.0 United States | * |
| dc.rights.uri | http://creativecommons.org/licenses/by-nc-nd/3.0/us/ | * |
| dc.title.en | Efficacy and Safety of Intravitreal Aflibercept Treat-and-Extend for Macular Edema in Central Retinal Vein Occlusion: The CENTERA Study | |
| dc.title.alternative | Am J Ophthalmol | en_US |
| dc.type | Article de revue | en_US |
| dc.identifier.doi | 10.1016/j.ajo.2021.01.027 | en_US |
| dc.subject.hal | Sciences du Vivant [q-bio]/Santé publique et épidémiologie | en_US |
| dc.identifier.pubmed | 33556381 | en_US |
| bordeaux.journal | American Journal of Ophthalmology | en_US |
| bordeaux.hal.laboratories | Bordeaux Population Health Research Center (BPH) - U1219 | en_US |
| bordeaux.institution | Université de Bordeaux | en_US |
| bordeaux.team | LEHA_BPH | |
| bordeaux.peerReviewed | oui | en_US |
| bordeaux.inpress | non | en_US |
| hal.identifier | hal-03188908 | |
| hal.version | 1 | |
| hal.date.transferred | 2021-04-02T13:29:56Z | |
| hal.audience | Internationale | |
| hal.export | true | |
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