Special Drug Use Observational Study With Beovu Kit for Intravitreal Injection
brief summary
This was a primary data collection-based observational special drug-use surveillance to be conducted in accordance with the Good Post-marketing Study Practice (GPSP) ordinance.
detailed description
This study aimed to evaluate the safety of Beovu kit for intravitreal injection in clinical use in diabetic macular edema (DME) patients.
The observation period was 1 year (52 weeks) from the first Beovu administration in the primary treated eye.
In patients discontinuing treatment with Beovu in the primary treated eye before Week 52, the following observation periods applied.
* Date of last Beovu dose + 90 days\* in primary treated eye \> Week 52: up to Week 52 * Date of last Beovu dose + 90 days\* in primary treated eye ≤ Week 52: up to last dosing date in the primary treated eye + 90 days \*90 days: to collect as much data as possible considering clinical effects
official title
Special Drug Use Observational Study With Beovu Kit for Intravitreal Injection (DME, CRTH258B1401)