Clinical trial NCT04632056: A 52-weeks Observational Study to Evaluate the Safety of Brolucizumab in Patients With nAMD
Official title: A 52-weeks Observational Study to Evaluate the Safety of Brolucizumab (6mg) in Patients With Neovascular Age-related Macular Degeneration (nAMD)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neovascular Age-related Macular Degeneration
Keywords: Japan
brolucizumab
neovascular age-related macular degeneration
(nAMD)
non-interventional study
post-marketing surveillance
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2020-11-17
Enrollment: 329
Sex: ALL
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population was patients using Beovu kit for intravitreal injection for nAMD with subfoveal CNV

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Patients must provide written consent to cooperate in this study before treatment with Beovu kit for intravitreal injection
2. Patients using Beovu kit for intravitreal injection for the first time for the following indication:

   * Indication: age-related macular degeneration with subfoveal choroidal neovascularization

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

Primary outcomes:
measure: Number of patients with adverse events in the eyes on therapy
timeFrame: 52 weeks
measure: Number of patients with adverse events in other parts of the body (non-ocular)
timeFrame: 52 weeks
Secondary outcomes:
measure: Number of patients with serious adverse events (SAEs) and adverse reactions (ADRs) in the eyes on therapy
timeFrame: 52 weeks
measure: Number of patients with SAEs and ADRs in other parts of the body (non-ocular)
timeFrame: 52 weeks
measure: Number of patients with adverse events, SAEs, ADRs and serious ADRs corresponding to the safety specifications
timeFrame: 52 weeks
measure: Incidence of adverse events by risk factor of the safety specifications (primary treated eyes only)
timeFrame: 52 weeks
measure: Proportion of patients with visual acuity (VA) worsening
timeFrame: 52 weeks
measure: Data on Beovu administration in the induction phase and maintenance phase
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Nagoya City
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Nagoya-city
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Nagoya
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Nagoya
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Nagoya
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Toyohashi
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Urayasu
country: Japan
facility: Novartis Investigative Site
state: Chiba
city: Iizuka
country: Japan
facility: Novartis Investigative Site
state: Fukuoka
city: Kurume city
country: Japan
facility: Novartis Investigative Site
state: Fukuoka
city: Kure
country: Japan
facility: Novartis Investigative Site
state: Hiroshima
city: Hakodate-city
country: Japan
facility: Novartis Investigative Site
state: Hokkaido
city: Hakodat
country: Japan
facility: Novartis Investigative Site
state: Hokkaido
city: Sapporo
country: Japan
facility: Novartis Investigative Site
state: Hokkaido
city: Kakogawa-shi
country: Japan
facility: Novartis Investigative Site
state: Hyogo
city: Kobe
country: Japan
facility: Novartis Investigative Site
state: Hyogo
city: Kobe
country: Japan
facility: Novartis Investigative Site
state: Hyogo
city: Nishinomiya
country: Japan
facility: Novartis Investigative Site
state: Hyogo
city: Ishioka
country: Japan
facility: Novartis Investigative Site
state: Ibaraki
city: Mito
country: Japan
facility: Novartis Investigative Site
state: Ibaraki
city: Kanazawa
country: Japan
facility: Novartis Investigative Site
state: Ishikawa
city: Kita-gun
country: Japan
facility: Novartis Investigative Site
state: Kagawa
city: Yokohama city
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Yokosuka-city
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Kumamoto City
country: Japan
facility: Novartis Investigative Site
state: Kumamoto
city: Yokkaichi
country: Japan
facility: Novartis Investigative Site
state: Mie
city: Kesennuma
country: Japan
facility: Novartis Investigative Site
state: Miyagi
city: Sendai city
country: Japan
facility: Novartis Investigative Site
state: Miyagi
city: Sendai
country: Japan
facility: Novartis Investigative Site
state: Miyagi
city: Miyakonojo
country: Japan
facility: Novartis Investigative Site
state: Miyazaki
city: Matsumoto
country: Japan
facility: Novartis Investigative Site
state: Nagano
city: Nagasaki-shi
country: Japan
facility: Novartis Investigative Site
state: Nagasaki
city: Kashihara city
country: Japan
facility: Novartis Investigative Site
state: Nara
city: Okayama-city
country: Japan
facility: Novartis Investigative Site
state: Okayama
city: Nakagami
country: Japan
facility: Novartis Investigative Site
state: Okinawa
city: Urazoe
country: Japan
facility: Novartis Investigative Site
state: Okinawa
city: Hirakata-city
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Moriguchi
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Osaka Sayama
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Osaka-city
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Sakai-city
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Suita
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Iruma-gun
country: Japan
facility: Novartis Investigative Site
state: Saitama
city: Saitama-shi
country: Japan
facility: Novartis Investigative Site
state: Saitama
city: Ohtsu-city
country: Japan
facility: Novartis Investigative Site
state: Shiga
city: Ohtsu-city
country: Japan
facility: Novartis Investigative Site
state: Shiga
city: Oda
country: Japan
facility: Novartis Investigative Site
state: Shimane
city: Hamamatsu-city
country: Japan
facility: Novartis Investigative Site
state: Shizuoka
city: Izunokuni
country: Japan
facility: Novartis Investigative Site
state: Shizuoka
city: Shizuoka-City
country: Japan
facility: Novartis Investigative Site
state: Shizuoka
city: Shimotsuke
country: Japan
facility: Novartis Investigative Site
state: Tochigi
city: Bunkyo ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Bunkyo ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Chiyoda-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Hachioji-city
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Musashino
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Shinjuku ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Akita
country: Japan
facility: Novartis Investigative Site
city: Fukuoka
country: Japan
facility: Novartis Investigative Site
city: Fukuoka
country: Japan
facility: Novartis Investigative Site
city: Fukuoka
country: Japan
facility: Novartis Investigative Site
city: Fukuoka
country: Japan
facility: Novartis Investigative Site
city: Hiroshima
country: Japan
facility: Novartis Investigative Site
city: Kyoto
country: Japan
facility: Novartis Investigative Site
city: Nagasaki
country: Japan
facility: Novartis Investigative Site
city: Okayama
country: Japan
facility: Novartis Investigative Site
city: Osaka
country: Japan
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: