A 52-weeks Observational Study to Evaluate the Safety of Brolucizumab (6mg) in Patients With Neovascular Age-related Macular Degeneration (nAMD)
A 52-weeks Observational Study to Evaluate the Safety of Brolucizumab (6mg) in Patients With Neovascular Age-related Macular Degeneration (nAMD)
This study was a prospective, uncontrolled, central registration system, multicenter, domestic observational study (special drug-use surveillance) to evaluate the safety of 52-week clinical treatment with Beovu kit for intravitreal injection in nAMD patients.
The observational period was 1 year (52 weeks) from the first brolucizumab administration in the primary treated eye.
However, if brolucizumab was discontinued in the primary treated eye and if the treatment was discontinued less than 52 weeks observation period, the observation period was to be up to 90 days after the last dose of this drug. This was set in order to collect data as much as possible based on the clinical effect of the drug. If 30 days after the last dose of this drug in a discontinued patient exceeds 52 weeks of the observation period, the patient was to be monitored for adverse events until 30 days after the last dose of this drug.
Inclusion Criteria:
Patients must provide written consent to cooperate in this study before treatment with Beovu kit for intravitreal injection
Patients using Beovu kit for intravitreal injection for the first time for the following indication:
Exclusion Criteria:
1. Patients with a history of treatment with a drug containing the same ingredient (brolucizumab; investigational drug or post-marketing clinical study drug) as Beovu kit for intravitreal injection
Hakodat, Hokkaido 041-0806, Japan
Kakogawa-shi, Hyōgo 675-8611, Japan
Kita-gun, Kagawa-ken 761-0793, Japan
Nakagami, Okinawa 903 0215, Japan
Iruma-gun, Saitama 350-0495, Japan
Saitama-shi, Saitama 336-0963, Japan
Ohtsu-city, Shiga 520-0046, Japan
Ohtsu-city, Shiga 520-2192, Japan
Bunkyo Ku, Tokyo 113 8655, Japan
Bunkyo Ku, Tokyo 113-8431, Japan
Chiyoda-ku, Tokyo 101-8309, Japan
Shinjuku Ku, Tokyo 162 8666, Japan
Shinjuku-ku, Tokyo 160 8582, Japan