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dc.rights.licenseopenen_US
dc.contributor.authorKODJIKIAN, Laurent
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorDELCOURT, Cécile
ORCID: 0000-0002-2099-0481
IDREF: 035105291
dc.contributor.authorCREUZOT-GARCHER, Catherine
dc.contributor.authorMASSIN, Pascale
dc.contributor.authorCONRATH, John
dc.contributor.authorVELARD, Marie-Eve
dc.contributor.authorLASSALLE, Thibaut
dc.contributor.authorPINCHINAT, Sybil
dc.contributor.authorDUPONT-BENJAMIN, Laure
dc.date.accessioned2023-04-18T08:47:00Z
dc.date.available2023-04-18T08:47:00Z
dc.date.issued2023-03-26
dc.identifier.issn2193-8245 (Print)en_US
dc.identifier.urihttps://oskar-bordeaux.fr/handle/20.500.12278/173047
dc.description.abstractEnINTRODUCTION: To evaluate real-world efficacy, safety, and treatment patterns with the dexamethasone intravitreal implant (DEX) in diabetic macular edema (DME) in France. METHODS: In this prospective, multicenter, observational, noncomparative, post-reimbursement study, consecutively enrolled patients with DME had a baseline evaluation on day 0. Those treated with DEX on day 0 were to be reevaluated at week 6 and months 6, 12, 18, and 24. DEX retreatment and/or alternative therapies were allowed during follow-up. The primary outcome measure was the maximum best corrected visual acuity (BCVA) gain from baseline during follow-up. Secondary outcome measures included time to maximum BCVA gain, patients (%) with prespecified BCVA gains from baseline at each visit, maximum central retinal thickness (CRT) reduction from baseline, patients (%) with CRT reduction ≥ 20% from baseline at each visit, patients (%) with DME resolution (per investigator judgement), and adverse events (AEs). RESULTS: Of 112 patients/eyes with DME for 3.5 years (mean) at baseline, 80 (including 86.1% previously treated) received DEX on day 0 and were analyzed for efficacy. Early study termination precluded collection of ≥ 12-month efficacy data. Patients received 1.4 DEX injections over 8.3 months (averages). The maximum BCVA gain from baseline was 3.6 letters, reached after 77.2 days (averages); 24.6% (week 6) and 15.0% (month 6) of patients experienced ≥ 10-letter BCVA gains from baseline. The mean maximum CRT reduction from baseline was -146.4 µm; 61.4% (week 6) and 36.0% (month 6) of patients had CRT reductions ≥ 20% from baseline, and 68.1% reported DME resolution at least once during follow-up. Ocular hypertension (n = 8, 12.1%) was the most frequent treatment-related AE. CONCLUSIONS: LOUVRE 3 confirmed that DEX improves BCVA and CRT, even in a patient population that had predominantly received DEX before enrollment in the study, and showed that DME resolution was observed during follow-up. DEX tolerability was consistent with published data, supporting treatment benefits in DME. GOV IDENTIFIER: NCT03003416.
dc.language.isoENen_US
dc.rightsAttribution-NonCommercial 3.0 United States*
dc.rights.urihttp://creativecommons.org/licenses/by-nc/3.0/us/*
dc.subject.enDexamethasone
dc.subject.enDiabetic macular edema
dc.subject.enFrance
dc.subject.enImplant
dc.subject.enIntravitreal
dc.subject.enReal-world evidence
dc.subject.enVisual acuity
dc.title.enProspective, Observational, Multicenter, Real-World Study of the Efficacy, Safety, and Pattern of Use of the Dexamethasone Intravitreal Implant in Diabetic Macular Edema in France: Short-Term Outcomes of LOUVRE 3
dc.title.alternativeOphthalmol Theren_US
dc.typeArticle de revueen_US
dc.identifier.doi10.1007/s40123-023-00662-8en_US
dc.subject.halSciences du Vivant [q-bio]/Santé publique et épidémiologieen_US
dc.identifier.pubmed36967448en_US
bordeaux.journalOphthalmology and Therapyen_US
bordeaux.hal.laboratoriesBordeaux Population Health Research Center (BPH) - UMR 1219en_US
bordeaux.institutionUniversité de Bordeauxen_US
bordeaux.institutionINSERMen_US
bordeaux.teamLEHA_BPHen_US
bordeaux.peerReviewedouien_US
bordeaux.inpressnonen_US
hal.identifierhal-04072536
hal.version1
hal.date.transferred2023-04-18T08:47:08Z
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=Ophthalmology%20and%20Therapy&rft.date=2023-03-26&rft.eissn=2193-8245%20(Print)&rft.issn=2193-8245%20(Print)&rft.au=KODJIKIAN,%20Laurent&DELCOURT,%20C%C3%A9cile&CREUZOT-GARCHER,%20Catherine&MASSIN,%20Pascale&CONRATH,%20John&rft.genre=article


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