Kaiser Peter K, Kampik Anselm, Kuppermann Baruch D, Girach Aniz, Rizzo Stanislao, Sergott Robert C
*Department of Ophthalmology, Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio; †Department of Ophthalmology, Ludwig Maximilians University, Munich, Germany; ‡Retina Service, Gavin Herbert Eye Institute, University of California, Irvine, California; §NightstaRx Ltd., London, United Kingdom (formerly of ThromboGenics NV); ¶Santa Chiara Hospital, Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy; **Neuro-Ophthalmology Service at Wills Eye Hospital, Thomas Jefferson University, Philadelphia, Pennsylvania; and ††Optic Nerve Research Center, Claymont, Delaware.
Retina. 2015 Jun;35(6):1111-27. doi: 10.1097/IAE.0000000000000448.
To report the safety of intravitreal ocriplasmin injection based on 2 Phase 3 clinical trials in patients with symptomatic vitreomacular adhesion/vitreomacular traction, including when associated with full-thickness macular holes.
Safety analyses were based on 2 completed Phase 3 studies assessing intravitreal ocriplasmin injection. Adverse events (AEs), serious AEs, and suspected adverse drug reactions are reported. The authors also report AEs of special interest from 8 other completed Phase 2 studies and 2 ongoing studies.
A total of 465 eyes were injected with ocriplasmin (125 µg), and 187 eyes were treated with placebo injection in Phase 3 studies. Overall AE rate was 69.0% in the placebo group and 76.6% for ocriplasmin-treated patients. Most AEs were in the study eye, mild or moderate in severity, and transient. All suspected adverse drug reactions were ocular; the majority was nonserious, of mild intensity, and transient.
Intravitreal ocriplasmin injection provides a generally well-tolerated pharmacologic treatment option for patients with symptomatic vitreomacular adhesion/vitreomacular traction, including when associated with full-thickness macular holes ≤400 µm in diameter.
基于两项针对有症状性玻璃体黄斑粘连/玻璃体黄斑牵引患者（包括伴有直径≤400μm的全层黄斑裂孔患者）的3期临床试验，报告玻璃体内注射奥克纤溶酶的安全性。
安全性分析基于两项已完成的评估玻璃体内注射奥克纤溶酶的3期研究。报告了不良事件（AE）、严重不良事件和疑似药物不良反应。作者还报告了来自其他8项已完成的2期研究和2项正在进行的研究中特别关注的不良事件。
在3期研究中，共有465只眼注射了奥克纤溶酶（125μg），187只眼接受了安慰剂注射。安慰剂组的总体不良事件发生率为69.0%，奥克纤溶酶治疗患者为76.6%。大多数不良事件发生在研究眼，严重程度为轻度或中度，且为短暂性。所有疑似药物不良反应均为眼部反应；大多数为非严重、轻度且短暂性。
玻璃体内注射奥克纤溶酶为有症状性玻璃体黄斑粘连/玻璃体黄斑牵引患者（包括伴有直径≤400μm的全层黄斑裂孔患者）提供了一种总体耐受性良好的药物治疗选择。
