Special Drug Use Observational Study With Beovu Kit for Intravitreal Injection (DME, CRTH258B1401)
Special Drug Use Observational Study With Beovu Kit for Intravitreal Injection (DME, CRTH258B1401)
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.
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.
Inclusion Criteria:
Exclusion Criteria:
1. Patients with a history of treatment with a drug containing the same ingredient (brolucizumab) as Beovu
Yoshida-gun, Fukui 910-1193, Japan
Hakodat, Hokkaido 041-0806, Japan
Kita-gun, Kagawa-ken 761-0793, Japan
Iruma-gun, Saitama 350-0495, Japan
Ohtsu, Shiga 520-2192, Japan
Bunkyo Ku, Tokyo 113 8655, Japan
Chiyoda-ku, Tokyo 101-8309, Japan
Itabashi-ku, Tokyo 174-0053, Japan
Taito-ku, Tokyo 111-0051, Japan