EICHORCondition: Diabetic Macular Edema · Sponsor: Bio-Thera Solutions
This study is a multi-center, open, multiple-dose phase Ib/IIa clinical study evaluating the efficacy and safety of BAT5906 injection in patients with diabetic macular edema. BAT5906's phase I study on w-AMD shows that it is safe from 0.3-4.0 mg, and the higher dose (2.5 mg and 4 mg) may maintain the anti-VEGF effect for a longer time just like the same target drugs (such as brolucizumab and Abecip ) It has also been found in clinical studies that high doses can extend the dosing interval and reduce the dosing frequency. Therefore, in this study, two safe and effective doses were selected, and the optimal clinical effective dose and frequency of BAT5906 in DME were initially explored.
This description comes directly from the study's public registry record.
No contact information is available for this study as per the public registry record.
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| Peking Union Medical College Hospital, Chinese Academy of Medical Sciences | Beijiang, Beijing Municipality, China | — |
| Eye Hospital of China Academy of Chinese Medical Sciences | Beijing, China | — |
| Peking University First Hospital | Beijing, China | — |
| The First Affiliated Hospital of Bengbu Medical College | Bengbu, China | — |
| Sun Yat-sen Memorial Hospital, Sun Yat-sen University | Guangzhou, China | — |
| Zhejiang Provincial People's Hospital | Hangzhou, China | — |
| Henan Provincial Eye Hospital | Henan, China | — |
| Jieyang People's Hospital | Jieyang, China | — |
| The First Hospital of Jilin University | Jilin City, China | — |
| The Affiliated Eye Hospital of Nanchang University | Nanchang, China | — |
| Jiangsu Provincial Hospital of Traditional Chinese Medicine | Nanjing, China | — |
| Affiliated Hospital of Nantong University | Nantong, China | — |
+ 7 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT04772105