Real-Life Efficacy, Safety, and Use of Dexamethasone Intravitreal Implant in Posterior Segment Inflammation Due to Non-infectious Uveitis (LOUVRE 2 Study)
| dc.rights.license | open | en_US |
| dc.contributor.author | BODAGHI, Bahram | |
| dc.contributor.author | BREZIN, Antoine P. | |
| dc.contributor.author | WEBER, Michel | |
| hal.structure.identifier | Bordeaux population health [BPH] | |
| dc.contributor.author | DELCOURT, Cecile
ORCID: 0000-0002-2099-0481 IDREF: 035105291 | |
| dc.contributor.author | KODJIKIAN, Laurent | |
| dc.contributor.author | PROVOST, Alexandra | |
| dc.contributor.author | VELARD, Marie-Eve | |
| dc.contributor.author | BARNIER-RIPET, Doris | |
| dc.contributor.author | PINCHINAT, Sybil | |
| dc.contributor.author | DUPONT-BENJAMIN, Laure | |
| dc.date.accessioned | 2022-10-17T09:36:13Z | |
| dc.date.available | 2022-10-17T09:36:13Z | |
| dc.date.issued | 2022-07-08 | |
| dc.identifier.issn | 2193-8245 (Print) | en_US |
| dc.identifier.uri | https://oskar-bordeaux.fr/handle/20.500.12278/170030 | |
| dc.description.abstractEn | INTRODUCTION: To evaluate real-life efficacy, safety, and treatment patterns with the dexamethasone intravitreal implant (DEX) in posterior segment inflammation due to non-infectious uveitis (treatment-naïve or not) in French clinics. METHODS: In this prospective, multicenter, observational, non-comparative, post-reimbursement study, consecutive patients with posterior segment inflammation due to non-infectious uveitis were enrolled and evaluated at baseline (day 0). Those who received DEX on day 0 were re-evaluated at months 2, 6, and 18. Retreatment with DEX and/or alternative therapies was allowed during follow-up. PRIMARY OUTCOME: patients (%) with at least a 15-letter gain in best corrected visual acuity (BCVA) at 2 months. Secondary outcomes included patients (%) with at least 15-letter BCVA gains at 6 and 18 months; mean BCVA change from baseline at 2, 6, and 18 months; and patients (%) retreated, mean central retinal thickness (CRT), and adverse events (AEs) at all post-baseline visits. RESULTS: Ninety-seven of 245 enrolled patients with posterior segment inflammation due to non-infectious uveitis (80% previously treated) and disease duration of 5 years (average) received DEX on day 0 and were included in efficacy analyses. At month 2 (n = 91), 20.5% of patients (95% CI 12.0-28.9) gained at least 15 letters from a baseline mean of 60.9 letters; the mean gain was 6.2 letters (95% CI 3.5-8.9). At month 6, 50.0% (n = 38/76) of patients did not receive alternative treatment or DEX retreatment, mostly because inflammation had sufficiently subsided (n = 27/38, 71.1%). Although early study termination prevented efficacy analysis at 18 months (n = 12), CRT reductions persisted throughout follow-up. From baseline to month 18, 21/245 (8.6%) patients had DEX-related AEs; 17/245 (6.9%) had ocular hypertension (most common AE). CONCLUSION: LOUVRE 2 confirms DEX efficacy on visual acuity and CRT in predominantly DEX-pretreated patients with relatively old/stabilized uveitis. DEX tolerability was consistent with known/published data, confirming treatment benefits in posterior segment inflammation due to non-infectious uveitis. GOV IDENTIFIER: NCT02951975. | |
| 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 | France | |
| dc.subject.en | Intravitreal | |
| dc.subject.en | Real-world evidence | |
| dc.subject.en | Uveitis | |
| dc.title.en | Real-Life Efficacy, Safety, and Use of Dexamethasone Intravitreal Implant in Posterior Segment Inflammation Due to Non-infectious Uveitis (LOUVRE 2 Study) | |
| dc.type | Article de revue | en_US |
| dc.identifier.doi | 10.1007/s40123-022-00525-8 | en_US |
| dc.subject.hal | Sciences du Vivant [q-bio]/Santé publique et épidémiologie | en_US |
| dc.identifier.pubmed | 35802252 | en_US |
| bordeaux.journal | Ophthalmology and Therapy | en_US |
| bordeaux.page | 1775–1792 | en_US |
| bordeaux.volume | 11 | 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 |
| bordeaux.identifier.funderID | Allergan | en_US |
| hal.identifier | hal-03817458 | |
| hal.version | 1 | |
| hal.date.transferred | 2022-10-17T09:36:17Z | |
| hal.export | true | |
| dc.rights.cc | Pas de Licence CC | en_US |
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