In:
Ophthalmic Research, S. Karger AG, Vol. 62, No. 2 ( 2019), p. 101-110
Abstract:
〈 b 〉 〈 i 〉 Purpose: 〈 /i 〉 〈 /b 〉 To report the real-world effectiveness and safety of ranibizumab 0.5 mg in patients with visual impairment due to diabetic macular edema (DME). 〈 b 〉 〈 i 〉 Methods: 〈 /i 〉 〈 /b 〉 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, precision = 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. 〈 b 〉 〈 i 〉 Results: 〈 /i 〉 〈 /b 〉 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 μm (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 & #x3e;70 letters versus 13.2% at baseline. Mean change in CSFT was −125 μm (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. 〈 b 〉 〈 i 〉 Conclusions: 〈 /i 〉 〈 /b 〉 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.
Type of Medium:
Online Resource
ISSN:
0030-3747
,
1423-0259
Language:
English
Publisher:
S. Karger AG
Publication Date:
2019
detail.hit.zdb_id:
205708-6
detail.hit.zdb_id:
1483177-6
