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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Beovu | Brolucizumab (Genetical Recombination) 6 mg (0.05 mL) was administered by intravitreal injection every 4 weeks for the first three doses(loading phase). In the following maintenance phase, Brolucizumab was basically administered every 12 weeks. The interval between treatments was adjusted as appropriate according to the symptoms. The interval between two doses was not to be shorter than 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Beovu | Drug | There is no treatment allocation. Patients administered Beovu by prescription that have started before inclusion of the patient into the study were enrolled. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 52 weeks |
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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
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The population was patients using Beovu kit for intravitreal injection for nAMD with subfoveal CNV
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Nagoya | Aichi-ken | 456-0032 | Japan | ||
| Novartis Investigative Site |
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| Label | URL |
|---|---|
| Results for CRTH258A1401 that is getting linked from the Novartis Clinical Trials Website | View source |
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|
| 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. | 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:
| 52 weeks |
| 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 | 52 weeks |
| Proportion of patients with visual acuity (VA) worsening | Visual acuity commonly refers to the clarity of vision | 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. | 52 weeks |
| Nagoya |
| Aichi-ken |
| 457 8510 |
| Japan |
| Novartis Investigative Site | Nagoya | Aichi-ken | 460-0008 | Japan |
| Novartis Investigative Site | Nagoya | Aichi-ken | 462-0825 | Japan |
| Novartis Investigative Site | Nagoya | Aichi-ken | 466 8560 | Japan |
| Novartis Investigative Site | Toyohashi | Aichi-ken | 441-8106 | Japan |
| Novartis Investigative Site | Urayasu | Chiba | 279-0021 | Japan |
| Novartis Investigative Site | Iizuka | Fukuoka | 820-0043 | Japan |
| Novartis Investigative Site | Kurume | Fukuoka | 830-0011 | Japan |
| Novartis Investigative Site | Kure | Hiroshima | 737-0029 | Japan |
| Novartis Investigative Site | Hakodate | Hokkaido | 041-0851 | Japan |
| Novartis Investigative Site | Hakodat | Hokkaido | 041-0806 | Japan |
| Novartis Investigative Site | Sapporo | Hokkaido | 060-0010 | Japan |
| Novartis Investigative Site | Kakogawa-shi | Hyōgo | 675-8611 | Japan |
| Novartis Investigative Site | Kobe | Hyōgo | 650-0047 | Japan |
| Novartis Investigative Site | Kobe | Hyōgo | 652-0863 | Japan |
| Novartis Investigative Site | Nishinomiya | Hyōgo | 663 8501 | Japan |
| Novartis Investigative Site | Ishioka | Ibaraki | 315-0037 | Japan |
| Novartis Investigative Site | Mito | Ibaraki | 310-0845 | Japan |
| Novartis Investigative Site | Kanazawa | Ishikawa-ken | 921-8161 | Japan |
| Novartis Investigative Site | Kita-gun | Kagawa-ken | 761-0793 | Japan |
| Novartis Investigative Site | Yokohama | Kanagawa | 232 0024 | Japan |
| Novartis Investigative Site | Yokosuka | Kanagawa | 238-8558 | Japan |
| Novartis Investigative Site | Kumamoto | Kumamoto | 860-8556 | Japan |
| Novartis Investigative Site | Yokkaichi | Mie-ken | 510-8567 | Japan |
| Novartis Investigative Site | Kesennuma | Miyagi | 988-0052 | Japan |
| Novartis Investigative Site | Sendai | Miyagi | 980 8574 | Japan |
| Novartis Investigative Site | Sendai | Miyagi | 980-0824 | Japan |
| Novartis Investigative Site | Miyakonojō | Miyazaki | 885-0000 | Japan |
| Novartis Investigative Site | Matsumoto | Nagano | 390-8621 | Japan |
| Novartis Investigative Site | Nagasaki | Nagasaki | 852-8511 | Japan |
| Novartis Investigative Site | Kashihara | Nara | 634 8522 | Japan |
| Novartis Investigative Site | Okayama | Okayama-ken | 700-8558 | Japan |
| Novartis Investigative Site | Nakagami | Okinawa | 903 0215 | Japan |
| Novartis Investigative Site | Urazoe | Okinawa | 901-2133 | Japan |
| Novartis Investigative Site | Hirakata | Osaka | 573-1191 | Japan |
| Novartis Investigative Site | Moriguchi | Osaka | 570-8507 | Japan |
| Novartis Investigative Site | Osaka | Osaka | 543-8555 | Japan |
| Novartis Investigative Site | Ōsaka-sayama | Osaka | 589 8511 | Japan |
| Novartis Investigative Site | Sakai | Osaka | 593-8304 | Japan |
| Novartis Investigative Site | Suita | Osaka | 565 0871 | Japan |
| Novartis Investigative Site | Iruma-gun | Saitama | 350-0495 | Japan |
| Novartis Investigative Site | Saitama-shi | Saitama | 336-0963 | Japan |
| Novartis Investigative Site | Ohtsu-city | Shiga | 520-0046 | Japan |
| Novartis Investigative Site | Ohtsu-city | Shiga | 520-2192 | Japan |
| Novartis Investigative Site | Oda | Shimane | 694-0064 | Japan |
| Novartis Investigative Site | Hamamatsu | Shizuoka | 430-8558 | Japan |
| Novartis Investigative Site | Izunokuni | Shizuoka | 410-2295 | Japan |
| Novartis Investigative Site | Shizuoka | Shizuoka | 422-8076 | Japan |
| Novartis Investigative Site | Shimotsuke | Tochigi | 329-0498 | Japan |
| Novartis Investigative Site | Bunkyo Ku | Tokyo | 113 8655 | Japan |
| Novartis Investigative Site | Bunkyo Ku | Tokyo | 113-8431 | Japan |
| Novartis Investigative Site | Chiyoda-ku | Tokyo | 101-8309 | Japan |
| Novartis Investigative Site | Hachiōji | Tokyo | 193-0944 | Japan |
| Novartis Investigative Site | Musashino | Tokyo | 180-0006 | Japan |
| Novartis Investigative Site | Shinjuku Ku | Tokyo | 162 8666 | Japan |
| Novartis Investigative Site | Shinjuku-ku | Tokyo | 160 8582 | Japan |
| Novartis Investigative Site | Akita | 010-8543 | Japan |
| Novartis Investigative Site | Fukuoka | 814-0011 | Japan |
| Novartis Investigative Site | Fukuoka | 814-0013 | Japan |
| Novartis Investigative Site | Fukuoka | 814-0193 | Japan |
| Novartis Investigative Site | Fukuoka | 819-8585 | Japan |
| Novartis Investigative Site | Hiroshima | 731-5133 | Japan |
| Novartis Investigative Site | Kyoto | 604-0837 | Japan |
| Novartis Investigative Site | Nagasaki | 850-0918 | Japan |
| Novartis Investigative Site | Okayama | 701-0153 | Japan |
| Novartis Investigative Site | Osaka | 545-8586 | Japan |
| ID | Term |
|---|---|
| C000622091 | brolucizumab |
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