Ricci Federico, Staurenghi Giovanni, Varano Monica, Eandi Chiara, Sinibaldi Tommaso Lupieri, Colombo Laura, Bartezaghi Marta, Bassanini Stefania
Retina Diseases Unit, Referral Center for Diagnosis and Therapy of AMD and Sight Threatening Retinal Diseases, PTV Foundation/Tor Vergata University, Viale Oxford, 81, 00133, Rome, Italy.
Department of Biomedical and Clinical Science Luigi Sacco, Luigi Sacco Hospital, University of Milan, Milan, Italy.
Graefes Arch Clin Exp Ophthalmol. 2019 Apr;257(4):759-768. doi: 10.1007/s00417-019-04248-8. Epub 2019 Jan 24.
To evaluate criteria driving retreatment with ranibizumab in Italian patients with myopic choroidal neovascularization (mCNV).
OLIMPIC was a 12-month, phase IIIb, open-label study. Patients with active mCNV were treated with ranibizumab 0.5 mg according to the European label. The study assessed local criteria in Italy driving retreatment decisions with ranibizumab; and the efficacy, safety, and tolerability of ranibizumab.
The mean (standard deviation [SD]) age of treated patients (N = 200) was 61.8 (12.7) years; range 22-85 years. The multivariate regression model indicated that presence of active leakage (odds ratio [OR] 95% confidence interval [CI]: 11.30 [1.03-124.14]), presence of intraretinal fluid (OR [95%CI]: 28.21 [1.55-513.73]), and an improvement in best-corrected visual acuity (BCVA) from baseline < 10 letters (OR [95%CI]: 17.60 [1.39-222.75]) were the factors with the greatest effect on retreatment with ranibizumab. The mean (SD) BCVA gain from baseline to month 12 was 8.4 (12.8) letters (P < 0.0001). The mean (SD) number of injections was 2.41 (1.53); range 1-9. Ocular and non-ocular adverse events were reported in 41 (20.5%) and 30 (15.0%) patients, respectively.
Individualized treatment with ranibizumab was effective in improving BCVA in patients with mCNV over 12 months. Both anatomical and functional variables had significant effects on causing retreatment. There were no new safety findings.
www.ClinicalTrials.Gov (NCT No: NCT02034006).
评估驱动意大利近视性脉络膜新生血管（mCNV）患者使用雷珠单抗进行再治疗的标准。
OLIMPIC是一项为期12个月的IIIb期开放标签研究。活动性mCNV患者根据欧洲标签使用0.5mg雷珠单抗进行治疗。该研究评估了意大利驱动雷珠单抗再治疗决策的局部标准；以及雷珠单抗的疗效、安全性和耐受性。
接受治疗的患者（N = 200）的平均（标准差[SD]）年龄为61.8（12.7）岁；年龄范围为22 - 85岁。多变量回归模型表明，活动性渗漏的存在（比值比[OR] 95%置信区间[CI]：11.30 [1.03 - 124.14]）、视网膜内液的存在（OR [95%CI]：28.21 [1.55 - 513.73]）以及最佳矫正视力（BCVA）较基线提高<10个字母（OR [95%CI]：17.60 [1.39 - 222.75]）是对雷珠单抗再治疗影响最大的因素。从基线到第12个月，BCVA平均（SD）提高了8.4（12.8）个字母（P < 0.0001）。平均（SD）注射次数为2.41（1.53）次；范围为1 - 9次。分别有41例（20.5%）和30例（15.0%）患者报告了眼部和非眼部不良事件。
雷珠单抗个体化治疗在12个月内有效改善了mCNV患者的BCVA。解剖学和功能变量对导致再治疗均有显著影响。未发现新的安全性问题。
