JPRN-jRCT1080223554已完成4 期
A 24-month, phase IV, open-label, single arm, multicenter, prospective, observational study assessing the efficacy and safety of subsequent treatment after initiation of intravitreal injection of ranibizumab 0.5 mg in diabetic macular edema patients with impaired visual acuity through individualized treatment in routine clinical practice in Japan
ovartis Pharma K.K.0 个研究点目标入组 209 人开始时间: 2017年6月7日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 209
研究概览
简要总结
The BCVA improvement in the study is comparable with results from other real-world studies, and is not inferior to that of results from randomized clinical trials. Safety data were consistent with the well-established profile of ranibizumab in the treatment of patients with impaired VA due to DME, with no new safety issues. The psychological results showed that potential positive effects on anxiety were observed with ranibizumab treatment and psychological symptoms for depression didn't worsen.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •* DME patients with impaired VA aged 20 years or older.
- •* Patients to whom ranibizumab treatment is considered as suitable and who are initiating treatment with ranibizumab for the first time.
- •* Patients not previously treated with any anti-VEGF agents including ranibizumab.
- •* Patient who is expected to follow visit schedule for at least one year.
- •* Willing and able to provide written informed consent personally or by a legally acceptable representative(s).
排除标准
- •* Simultaneous participation in a study that includes administration of any investigational drug or procedure.
- •* Planned to be treated with systemic anti-VEGF agents within at least one year from baseline.
- •* Patients contraindicated for ranibizumab treatment as per the Japan package insert:
- •* Patients with a history of hypersensitivity to the ingredients in ranibizumab formulation.
- •* Patients with infection or patients with suspected infection in and/or around the eye.
- •* Patients with inflammation in and/or around the eye.
研究者
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