Prospective, 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.rights.license | open | en_US |
| dc.contributor.author | KODJIKIAN, Laurent | |
| hal.structure.identifier | Bordeaux population health [BPH] | |
| dc.contributor.author | DELCOURT, Cécile
ORCID: 0000-0002-2099-0481 IDREF: 035105291 | |
| dc.contributor.author | CREUZOT-GARCHER, Catherine | |
| dc.contributor.author | MASSIN, Pascale | |
| dc.contributor.author | CONRATH, John | |
| dc.contributor.author | VELARD, Marie-Eve | |
| dc.contributor.author | LASSALLE, Thibaut | |
| dc.contributor.author | PINCHINAT, Sybil | |
| dc.contributor.author | DUPONT-BENJAMIN, Laure | |
| dc.date.accessioned | 2023-04-18T08:47:00Z | |
| dc.date.available | 2023-04-18T08:47:00Z | |
| dc.date.issued | 2023-03-26 | |
| dc.identifier.issn | 2193-8245 (Print) | en_US |
| dc.identifier.uri | https://oskar-bordeaux.fr/handle/20.500.12278/173047 | |
| dc.description.abstractEn | INTRODUCTION: 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.iso | EN | en_US |
| dc.rights | Attribution-NonCommercial 3.0 United States | * |
| dc.rights.uri | http://creativecommons.org/licenses/by-nc/3.0/us/ | * |
| dc.subject.en | Dexamethasone | |
| dc.subject.en | Diabetic macular edema | |
| dc.subject.en | France | |
| dc.subject.en | Implant | |
| dc.subject.en | Intravitreal | |
| dc.subject.en | Real-world evidence | |
| dc.subject.en | Visual acuity | |
| dc.title.en | Prospective, 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.alternative | Ophthalmol Ther | en_US |
| dc.type | Article de revue | en_US |
| dc.identifier.doi | 10.1007/s40123-023-00662-8 | en_US |
| dc.subject.hal | Sciences du Vivant [q-bio]/Santé publique et épidémiologie | en_US |
| dc.identifier.pubmed | 36967448 | en_US |
| bordeaux.journal | Ophthalmology and Therapy | en_US |
| bordeaux.hal.laboratories | Bordeaux Population Health Research Center (BPH) - UMR 1219 | en_US |
| bordeaux.institution | Université de Bordeaux | en_US |
| bordeaux.institution | INSERM | en_US |
| bordeaux.team | LEHA_BPH | en_US |
| bordeaux.peerReviewed | oui | en_US |
| bordeaux.inpress | non | en_US |
| hal.identifier | hal-04072536 | |
| hal.version | 1 | |
| hal.date.transferred | 2023-04-18T08:47:08Z | |
| hal.export | true | |
| dc.rights.cc | Pas de Licence CC | en_US |
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