| Company Name | Bayer Taiwan Co., Ltd. |
|---|---|
| Protocol Number | 19157 |
| Title of Study | AURIGA / An observationAl stUdy pRogram to InvestiGate the effectiveness of intravitreal Aflibercept in diabetic macular edema and/or macular edema secondary to retinal vein occlusion in a real world setting. |
| Primary Objective | AURIGA is designed to collect data from routine clinical practice on intravitreal aflibercept in the treatment of visual impairment due to DME or macular edema seconday to RVO. The primary objective of this OS is to evaluate the effectiveness of intravitreal aflibercept in 4 cohorts (with/without prior treatment in DME ormacular edema secondary to RVO patients) in each of the participating countries |
| Number of Sites | 11 |
| Period of Study | From：2018 Q4 to：2020 Q2 |
| Number of Patients | Taiwan greater or equal to 410人人 |
| IRB Approval Date | TPVGH 25Jun2018 NTUH 10Sep2018 CCH 20Sep2018 CMH Pending MMH 20Sep2018 KHVGH 04Oct2018 TSGH Pending NCKUH 05Oct2018 CMUH 12Oct2018 SKH 21Sep2018 KMUH Pending |
| Publication Plan / Date | 2021 |
