Massin Pascale, Creuzot-Garcher Catherine, Kodjikian Laurent, Girmens Jean-François, Delcourt Cecile, Fajnkuchen Frank, Glacet-Bernard Agnès, Guillausseau Pierre-Jean, Ponthieux Anne, Blin Patrick, Grelaud Angela
Ophthalmology, Hopital Lariboisière, Paris, France.
Ophthalmology, University Hospital, Dijon, France.
Ophthalmic Res. 2019;62(2):101-110. doi: 10.1159/000497406. Epub 2019 Mar 29.
To report the real-world effectiveness and safety of ranibizumab 0.5 mg in patients with visual impairment due to diabetic macular edema (DME).
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.
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 > 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.
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.
报告0.5毫克雷珠单抗治疗糖尿病性黄斑水肿（DME）所致视力损害患者的真实疗效和安全性。
这是一项为期36个月的法国多中心观察性队列研究。2013年12月至2015年4月期间，眼科医生纳入了年龄≥18岁、患有与DME相关视力损害且开始使用0.5毫克雷珠单抗的糖尿病患者。在此，我们展示该队列的12个月结果。主要终点是最佳矫正视力（BCVA）的平均变化；样本量计算基于RESTORE试验数据（BCVA平均变化 = 6.8个字母，精度 = 0.7个字母）。次要终点包括中心子野厚度（CSFT）的变化、就诊次数、接受的注射次数以及眼部和非眼部不良事件及严重不良事件的发生频率。
2013年12月至2015年4月期间，84名眼科医生共纳入290例DME患者；242例患者有12个月的数据（由于招募率低，对242例可评估患者重新计算了精度：此时精度为1.0个字母）。平均年龄（±标准差）为66.1±11.0岁，男性占56.6%。BCVA和CSFT的平均基线值分别为59.2个字母（95%置信区间[CI] 57.3, 61.0）和457μm（95% CI：438, 476）。在第12个月时，BCVA较基线的平均增益为7.4个字母（95% CI：5.4, 9.4），36.8%的患者BCVA>70个字母，而基线时为13.2%。CSFT的平均变化为 -125μm（95% CI：-146, -103）。雷珠单抗的平均注射次数为5.1±2.3次，平均就诊10.4±3.0次。未发现新的安全问题。
BOREAL研究证实了雷珠单抗在常规临床实践中治疗与DME相关视力损害的有效性和安全性，且注射次数少于临床试验报告。
