中心網膜静脈閉塞症（CRVO）に対するアイリーアの安全性に関する前向き非介入多施設共同市販後調査
基本情報
- NCT ID
- NCT02040220
- ステータス
- 完了
- 試験のフェーズ
- -
- 試験タイプ
- 観察
- 目標被験者数
- 385
- 治験依頼者名
- Bayer
概要
This is a prospective, non-interventional, multi center post-authorization safety study that includes patients with a diagnosis of CRVO. The investigator will have made the choice of treatment (EYLEA) as well as the decision to use EYLEA according the Japanese Package Insert prior to enrolling the patient in this study. The observation period for each patient starts when therapy with EYLEA is initiated. The enrollment period is 2 years. Patients will be followed for a time period of 2 years or until it is no longer possible (e.g. lost to follow-up) within the 2 years. For each patient, data are collected as defined in the case report form at the initial visit, follow-up visits and final visit, either by routine clinical visits (as per investigators routine practice). There will interim analysis of study data: 6 months after last patient first visit and J-PSUR(Japanese-Periodic Safety Update Report )