用Ranibizumab的港口输送系统治疗眼睛内炎:临床试验开发期间病例摘要
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Use of Rabbit Eyes in Pharmacokinetic Studies of Intraocular Drugs
Published on: July 23, 2016
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David A Eichenbaum1, William R Freeman2, Margaret A Chang3
1Retina Vitreous Associates of Florida, St Petersburg, Florida; Morsani College of Medicine, University of South Florida, Tampa, Florida.
Ophthalmology. Retina
|August 18, 2024
概括
端口输送系统 (PDS) 植入湿 AMD 后,内炎是一个严重的风险. 大多数病例是晚发的,与结膜问题有关,随着及时治疗,视力得到改善.
科学领域:
- 眼科医生 眼科 眼科
- 视网膜疾病 视网膜疾病
- 药物输送系统是药物输送系统.
背景情况:
- 使用拉尼比祖马布的港口输送系统 (PDS) 已被批准用于新血管与年龄相关的黄斑变性 (nAMD).
- 美国处方信息包括PDS植入后内炎的盒装警告.
- 本摘要回顾了与PDS相关的内眼炎病例,结果和潜在的风险因素.
研究的目的:
- 总结一下内炎病例,治疗结果,以及接受新血管与年龄相关的黄斑退行症的Port Delivery System (PDS) 患者的潜在促成因素.
- 分析PDS植入后内炎的发生率和特征.
- 讨论与PDS相关的内炎的潜在缓解策略.
主要方法:
- 从第二阶段梯子和第三阶段门和门户试验中对内炎病例的回顾性审查.
- 用PDS治疗的555名患者的聚合安全人群的分析.
- 病例的评估基于临床特征,管理,视觉结果以及与结膜并发症或补充程序的关联.
主要成果:
- 在555名患者中有11名 (2.0%) 发生了12次内炎事件.
- 大多数病例 (9/11) 是晚发病 (57-853天植入后),其中7例与结膜并发症有关.
- 在最后的随访中,7名患者恢复了视力至基线或更好,而4名患者视力下降.
结论:
- 视内膜炎是PDS植入后的重大风险,类似于其他眼部手术.
- 晚期发病的内炎,通常与结膜损伤有关,是一个值得注意的模式.
- 警地监测结膜和细致的外科手术技术对于最大限度地减少PDS相关的内炎风险至关重要,以及及时治疗.
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