Clinical trial NCT05526729: Special Drug Use Observational Study With Beovu Kit for Intravitreal Injection
Official title: Special Drug Use Observational Study With Beovu Kit for Intravitreal Injection (DME, CRTH258B1401)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Macular Edema
Keywords: diabetic macular edema
DME
NIS
Japan
PMS
Beovu
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2022-09-02
Enrollment: 222
Sex: ALL
Minimum age (years): 0
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: Patients using Beovu for the first time for diabetic macular edema in Japan

Brief summary: 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.

Detailed description: 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.

* Date of last Beovu dose + 90 days\* in primary treated eye \> Week 52: up to Week 52
* Date of last Beovu dose + 90 days\* in primary treated eye ≤ Week 52: up to last dosing date in the primary treated eye + 90 days \*90 days: to collect as much data as possible considering clinical effects

Eligibility criteria: Inclusion Criteria:

1. Patients must provide written consent to cooperate in this study before the start of treatment with Beovu
2. Patients using Beovu for the first time for the following indication • Indication: diabetic macular edema

Exclusion Criteria:

1. Patients with a history of treatment with a drug containing the same ingredient (brolucizumab) as Beovu

Primary outcomes:
measure: Proportion of patients with adverse events corresponding to each of the safety specifications during the observation period
timeFrame: Up to 52 weeks
measure: Proportions of patients with adverse events in the eyes on therapy during the observation period
timeFrame: Up to 52 weeks
measure: Proportion of patients with systemic adverse events during the observation period
timeFrame: Up to 52 weeks
Secondary outcomes:
measure: Proportion of patients with serious adverse events (SAEs) and adverse reactions in the eyes on therapy during the observation period
timeFrame: Up to 52 weeks
measure: Proportion of patients with systemic SAEs and adverse reactions during the observation period
timeFrame: Up to 52 weeks
measure: Proportion of patients with SAEs, adverse reactions and serious adverse reactions corresponding to the safety specifications during the observation period
timeFrame: Up to 52 weeks
measure: Incidences of adverse events by risk factor of the safety specifications
timeFrame: Up to 52 weeks
measure: Proportion of patients with VA worsening during the observation period
timeFrame: Up to 52 weeks
measure: Proportion of patients by administration status in the induction and maintenance phase during the observation period
timeFrame: Up to 52 weeks
measure: Proportion of patients by treated eye in the induction and maintenance phase during the observation period
timeFrame: Up to 52 weeks
Other outcomes:
Locations:
city: Nagakute-city
country: Japan
facility: Novartis Investigative Site
state: Aichi
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: Kashiwa
country: Japan
facility: Novartis Investigative Site
state: Chiba
city: Kisarazu
country: Japan
facility: Novartis Investigative Site
state: Chiba
city: Urayasu
country: Japan
facility: Novartis Investigative Site
state: Chiba
city: Urayasu
country: Japan
facility: Novartis Investigative Site
state: Chiba
city: Yoshida-gun
country: Japan
facility: Novartis Investigative Site
state: Fukui
city: Fukuoka city
country: Japan
facility: Novartis Investigative Site
state: Fukuoka
city: Kurume city
country: Japan
facility: Novartis Investigative Site
state: Fukuoka
city: Fukushima city
country: Japan
facility: Novartis Investigative Site
state: Fukushima
city: Mizunami
country: Japan
facility: Novartis Investigative Site
state: Gifu
city: Maebashi city
country: Japan
facility: Novartis Investigative Site
state: Gunma
city: Asahikawa
country: Japan
facility: Novartis Investigative Site
state: Hokkaido
city: Hakodate-city
country: Japan
facility: Novartis Investigative Site
state: Hokkaido
city: Hakodat
country: Japan
facility: Novartis Investigative Site
state: Hokkaido
city: Sapporo city
country: Japan
facility: Novartis Investigative Site
state: Hokkaido
city: Sapporo
country: Japan
facility: Novartis Investigative Site
state: Hokkaido
city: Kobe
country: Japan
facility: Novartis Investigative Site
state: Hyogo
city: Kobe
country: Japan
facility: Novartis Investigative Site
state: Hyogo
city: Nishinomiya-city
country: Japan
facility: Novartis Investigative Site
state: Hyogo
city: Sumoto
country: Japan
facility: Novartis Investigative Site
state: Hyogo
city: Takarazuka
country: Japan
facility: Novartis Investigative Site
state: Hyogo
city: Inashiki
country: Japan
facility: Novartis Investigative Site
state: Ibaraki
city: Ishioka
country: Japan
facility: Novartis Investigative Site
state: Ibaraki
city: Mito
country: Japan
facility: Novartis Investigative Site
state: Ibaraki
city: Kita-gun
country: Japan
facility: Novartis Investigative Site
state: Kagawa
city: Kagoshima city
country: Japan
facility: Novartis Investigative Site
state: Kagoshima
city: Yokohama
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Nankoku city
country: Japan
facility: Novartis Investigative Site
state: Kochi
city: Arao
country: Japan
facility: Novartis Investigative Site
state: Kumamoto
city: Yokkaichi
country: Japan
facility: Novartis Investigative Site
state: Mie
city: Miyakonojo
country: Japan
facility: Novartis Investigative Site
state: Miyazaki
city: Matsumoto
country: Japan
facility: Novartis Investigative Site
state: Nagano
city: Ueda
country: Japan
facility: Novartis Investigative Site
state: Nagano
city: Nagasaki-city
country: Japan
facility: Novartis Investigative Site
state: Nagasaki
city: Nagasaki-shi
country: Japan
facility: Novartis Investigative Site
state: Nagasaki
city: Kashihara city
country: Japan
facility: Novartis Investigative Site
state: Nara
city: Joetsu-City
country: Japan
facility: Novartis Investigative Site
state: Niigata
city: Sanjo
country: Japan
facility: Novartis Investigative Site
state: Niigata
city: Yufu
country: Japan
facility: Novartis Investigative Site
state: Oita
city: Kurashiki
country: Japan
facility: Novartis Investigative Site
state: Okayama
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: Sakai
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: Ohtsu
country: Japan
facility: Novartis Investigative Site
state: Shiga
city: Oda
country: Japan
facility: Novartis Investigative Site
state: Shimane
city: Shimotsuke
country: Japan
facility: Novartis Investigative Site
state: Tochigi
city: Bunkyo ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Chiyoda-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Edogawa
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Hachioji-city
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Hachioji
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Itabashi-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Katsushika-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Musashino
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Taito-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: Kumamoto
country: Japan
facility: Novartis Investigative Site
city: Kyoto
country: Japan
facility: Novartis Investigative Site
city: Kyoto
country: Japan
facility: Novartis Investigative Site
city: Nagasaki
country: Japan
facility: Novartis Investigative Site
city: Oita
country: Japan
facility: Novartis Investigative Site
city: Okayama
country: Japan
facility: Novartis Investigative Site
city: Okayama
country: Japan
facility: Novartis Investigative Site
city: Osaka
country: Japan
facility: Novartis Investigative Site
city: Osaka
country: Japan
facility: Novartis Investigative Site
city: Osaka
country: Japan
facility: Novartis Investigative Site
city: Toyama
country: Japan
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: