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.
Study Type
OBSERVATIONAL
Enrollment
329
There is no treatment allocation. Patients administered Beovu by prescription that have started before inclusion of the patient into the study were enrolled.
Number of patients with adverse events in the eyes on therapy
Number of patients with adverse events (AEs) in the eyes on therapy were reported
Time frame: 52 weeks
Number of patients with adverse events in other parts of the body (non-ocular)
Number of patients with adverse events (AEs) in other parts of the body (non-ocular) were reported
Time frame: 52 weeks
Number of patients with serious adverse events (SAEs) and adverse reactions (ADRs) in the eyes on therapy
A SAE is defined as an AE whose description suggests that it is serious or whose outcome is fatal. An adverse reaction is defined as an adverse event that is suspected by the investigator to be causally related to Beovu or administration procedures, or whose causality is not recorded.
Time frame: 52 weeks
Number of patients with SAEs and ADRs in other parts of the body (non-ocular)
A SAE is defined as an AE whose description suggests that it is serious or whose outcome is fatal. An adverse reaction is defined as an adverse event that is suspected by the investigator to be causally related to Beovu or administration procedures, or whose causality is not recorded.
Time frame: 52 weeks
Number of patients with adverse events, SAEs, ADRs and serious ADRs corresponding to the safety specifications
The following events were chosen as the safety specifications for this study that should be investigated: * Intraocular inflammation * Endophthalmitis * Increased intraocular pressure * Retinal pigment epithelial tear * Retinal detachment and retinal tear * Retinal artery embolic events * Non-ocular arterial thromboembolic events * Retinal vasculitis and retinal vascular occlusion
Time frame: 52 weeks
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Novartis Investigative Site
Nagoya, Aichi-ken, Japan
Novartis Investigative Site
Nagoya, Aichi-ken, Japan
Novartis Investigative Site
Nagoya, Aichi-ken, Japan
Novartis Investigative Site
Nagoya, Aichi-ken, Japan
Novartis Investigative Site
Nagoya, Aichi-ken, Japan
Novartis Investigative Site
Toyohashi, Aichi-ken, Japan
Novartis Investigative Site
Urayasu, Chiba, Japan
Novartis Investigative Site
Iizuka, Fukuoka, Japan
Novartis Investigative Site
Kurume, Fukuoka, Japan
Novartis Investigative Site
Kure, Hiroshima, Japan
...and 57 more locations
Incidence of adverse events by risk factor of the safety specifications (primary treated eyes only)
Incidence of adverse events by risk factor of the safety specifications (primary treated eyes only) were reported
Time frame: 52 weeks
Proportion of patients with visual acuity (VA) worsening
Visual acuity commonly refers to the clarity of vision
Time frame: 52 weeks
Data on Beovu administration in the induction phase and maintenance phase
For data on Beovu administration (dosing duration, dosing frequency) in the primary treated eye and the secondary primary eyes in the safety analysis set, summary statistics were calculated respectively. The same calculation applied to data on administration respectively for the induction period and the maintenance period.
Time frame: 52 weeks