Real-World Outcomes with Ranibizumab 0.5 mg in Patients with Visual Impairment due to Diabetic Macular Edema: 12-Month Results from the 36-Month BOREAL-DME Study
| dc.rights.license | open | en_US |
| dc.contributor.author | MASSIN, P. | |
| dc.contributor.author | CREUZOT-GARCHER, C. | |
| dc.contributor.author | KODJIKIAN, L. | |
| dc.contributor.author | GIRMENS, J. F. | |
| hal.structure.identifier | Bordeaux population health [BPH] | |
| dc.contributor.author | DELCOURT, Cecile
ORCID: 0000-0002-2099-0481 IDREF: 035105291 | |
| dc.contributor.author | FAJNKUCHEN, F. | |
| dc.contributor.author | GLACET-BERNARD, A. | |
| dc.contributor.author | GUILLAUSSEAU, P. J. | |
| dc.contributor.author | PONTHIEUX, A. | |
| dc.contributor.author | BLIN, Patrick | |
| dc.contributor.author | GRELAUD, A. | |
| dc.date.accessioned | 2020-06-29T10:02:56Z | |
| dc.date.available | 2020-06-29T10:02:56Z | |
| dc.date.issued | 2019-03-29 | |
| dc.identifier.issn | 1423-0259 (Electronic) 0030-3747 (Linking) | en_US |
| dc.identifier.uri | https://oskar-bordeaux.fr/handle/20.500.12278/8266 | |
| dc.description.abstractEn | PURPOSE: To report the real-world effectiveness and safety of ranibizumab 0.5 mg in patients with visual impairment due to diabetic macular edema (DME). METHODS: This is a French, 36-month, multicenter, observational cohort study. Between December 2013 and April 2015, ophthalmologists enrolled diabetic patients aged >/=18 years with DME-related visual impairment and for whom ranibizumab 0.5 mg was initiated. Here, we present the 12-month results from this cohort. The primary endpoint was the mean change in best-corrected visual acuity (BCVA); sample size calculations were based on RESTORE trial data (BCVA mean change = 6.8 letters, preci sion = 0.7 letters). Secondary endpoints included the change in central subfield thickness (CSFT), number of visits, number of injections received, and frequency of ocular and nonocular adverse events and serious adverse events. RESULTS: Between December 2013 and April 2015, a total of 290 patients with DME were enrolled by 84 ophthalmologists; 12-month data are available for 242 patients (due to low recruitment rates, precision was recalculated for 242 evaluable patients: the precision was then of 1.0 letters). Mean age (+/- standard deviation) was 66.1 +/- 11.0 years and 56.6% were male. The mean baseline BCVA and CSFT were 59.2 letters (95% confidence interval [CI] 57.3, 61.0) and 457 mum (95% CI: 438, 476), respectively. At month 12, the mean gain in BCVA from baseline was 7.4 letters (95% CI: 5.4, 9.4), with 36.8% of patients with BCVA > 70 letters versus 13.2% at baseline. Mean change in CSFT was -125 mum (95% CI: -146, -103). The mean number of ranibizumab injections was 5.1 +/- 2.3 over an average of 10.4 +/- 3.0 visits. No new safety findings were identified. CONCLUSIONS: The BOREAL study confirms the effectiveness and safety of ranibizumab for the treatment of DME-related visual impairment in routine clinical practice with fewer injections than reported in clinical trials. | |
| dc.language.iso | EN | en_US |
| dc.subject.en | LEHA | |
| dc.title.en | Real-World Outcomes with Ranibizumab 0.5 mg in Patients with Visual Impairment due to Diabetic Macular Edema: 12-Month Results from the 36-Month BOREAL-DME Study | |
| dc.type | Article de revue | en_US |
| dc.identifier.doi | 10.1159/000497406 | en_US |
| dc.subject.hal | Sciences du Vivant [q-bio]/Santé publique et épidémiologie | en_US |
| dc.identifier.pubmed | 30928985 | en_US |
| bordeaux.journal | Ophthalmic research | en_US |
| bordeaux.page | 101-110 | en_US |
| bordeaux.volume | 62 | en_US |
| bordeaux.hal.laboratories | Bordeaux Population Health Research Center (BPH) - UMR 1219 | en_US |
| bordeaux.issue | 2 | en_US |
| bordeaux.institution | Université de Bordeaux | en_US |
| bordeaux.team | LEHA_BPH | |
| bordeaux.peerReviewed | oui | en_US |
| bordeaux.inpress | non | en_US |
| hal.export | false | |
| bordeaux.COinS | ctx_ver=Z39.88-2004&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.jtitle=Ophthalmic%20research&rft.date=2019-03-29&rft.volume=62&rft.issue=2&rft.spage=101-110&rft.epage=101-110&rft.eissn=1423-0259%20(Electronic)%200030-3747%20(Linking)&rft.issn=1423-0259%20(Electronic)%200030-3747%20(Linking)&rft.au=MASSIN,%20P.&CREUZOT-GARCHER,%20C.&KODJIKIAN,%20L.&GIRMENS,%20J.%20F.&DELCOURT,%20Cecile&rft.genre=article |
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