Special Drug Use Observational Study With Beovu Kit for Intravitreal Injection

Diabetic Macular Edema Clinical Trial

Official title:

Special Drug Use Observational Study With Beovu Kit for Intravitreal Injection (DME, CRTH258B1401)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05526729
• Other study ID #: CRTH258B1401
• Status: Active, not recruiting
• Start date: September 2, 2022
• Est. completion date: June 29, 2024

Study information

• Verified date: May 2024
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a primary data collection-based observational special drug-use surveillance to be conducted in accordance with the Good Post-marketing Study Practice (GPSP) ordinance.

Description:

This study aims to evaluate the safety of Beovu kit for intravitreal injection in clinical use in diabetic macular edema (DME) patients.

The observation period is 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 will apply.

• 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 222
• Est. completion date: June 29, 2024
• Est. primary completion date: June 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Macular Edema

Intervention

Other:
• Beovu
Prospective observational study. There is no treatment allocation. Patients prescribed with Beovu for the first time for diabetic macular edema are eligible to enroll into this study.

Locations

Country	Name	City	State
Japan	Novartis Investigative Site	Akita
Japan	Novartis Investigative Site	Arao	Kumamoto
Japan	Novartis Investigative Site	Asahikawa-city	Hokkaido
Japan	Novartis Investigative Site	Bunkyo ku	Tokyo
Japan	Novartis Investigative Site	Chiyoda-ku	Tokyo
Japan	Novartis Investigative Site	Edogawa	Tokyo
Japan	Novartis Investigative Site	Fukuoka
Japan	Novartis Investigative Site	Fukuoka city	Fukuoka
Japan	Novartis Investigative Site	Fukushima city	Fukushima
Japan	Novartis Investigative Site	Hachioji-city	Tokyo
Japan	Novartis Investigative Site	Hachioji-city	Tokyo
Japan	Novartis Investigative Site	Hakodat	Hokkaido
Japan	Novartis Investigative Site	Hakodate-city	Hokkaido
Japan	Novartis Investigative Site	Hirakata-city	Osaka
Japan	Novartis Investigative Site	Inashiki-gun	Ibaraki
Japan	Novartis Investigative Site	Iruma-gun	Saitama
Japan	Novartis Investigative Site	Ishioka	Ibaraki
Japan	Novartis Investigative Site	Itabashi-ku	Tokyo
Japan	Novartis Investigative Site	Joetsu-City	Niigata
Japan	Novartis Investigative Site	Kagoshima city	Kagoshima
Japan	Novartis Investigative Site	Kashihara city	Nara
Japan	Novartis Investigative Site	Kashiwa	Chiba
Japan	Novartis Investigative Site	Katsushika-ku	Tokyo
Japan	Novartis Investigative Site	Kisarazu	Chiba
Japan	Novartis Investigative Site	Kita-gun	Kagawa
Japan	Novartis Investigative Site	Kobe	Hyogo
Japan	Novartis Investigative Site	Kobe	Hyogo
Japan	Novartis Investigative Site	Kumamoto City	Kumamoto
Japan	Novartis Investigative Site	Kurashiki-city	Okayama
Japan	Novartis Investigative Site	Kurume city	Fukuoka
Japan	Novartis Investigative Site	Kyoto
Japan	Novartis Investigative Site	Kyoto
Japan	Novartis Investigative Site	Maebashi city	Gunma
Japan	Novartis Investigative Site	Matsumoto	Nagano
Japan	Novartis Investigative Site	Mito	Ibaraki
Japan	Novartis Investigative Site	Miyakonojo	Miyazaki
Japan	Novartis Investigative Site	Mizunami	Gifu
Japan	Novartis Investigative Site	Moriguchi	Osaka
Japan	Novartis Investigative Site	Musashino	Tokyo
Japan	Novartis Investigative Site	Nagakute-city	Aichi
Japan	Novartis Investigative Site	Nagasaki
Japan	Novartis Investigative Site	Nagasaki-city	Nagasaki
Japan	Novartis Investigative Site	Nagasaki-shi	Nagasaki
Japan	Novartis Investigative Site	Nagoya	Aichi
Japan	Novartis Investigative Site	Nagoya City	Aichi
Japan	Novartis Investigative Site	Nagoya-city	Aichi
Japan	Novartis Investigative Site	Nagoya-city	Aichi
Japan	Novartis Investigative Site	Nagoya-city	Aichi
Japan	Novartis Investigative Site	Nankoku city	Kochi
Japan	Novartis Investigative Site	Nishinomiya-city	Hyogo
Japan	Novartis Investigative Site	Oda	Shimane
Japan	Novartis Investigative Site	Ohtsu-city	Shiga
Japan	Novartis Investigative Site	Oita
Japan	Novartis Investigative Site	Okayama
Japan	Novartis Investigative Site	Okayama-city	Okayama
Japan	Novartis Investigative Site	Osaka
Japan	Novartis Investigative Site	Osaka
Japan	Novartis Investigative Site	Osaka
Japan	Novartis Investigative Site	Osaka Sayama	Osaka
Japan	Novartis Investigative Site	Sakai-city	Osaka
Japan	Novartis Investigative Site	Sanjo	Niigata
Japan	Novartis Investigative Site	Sapporo	Hokkaido
Japan	Novartis Investigative Site	Sapporo city	Hokkaido
Japan	Novartis Investigative Site	Shimotsuke	Tochigi
Japan	Novartis Investigative Site	Suita	Osaka
Japan	Novartis Investigative Site	Sumoto	Hyogo
Japan	Novartis Investigative Site	Taito-ku	Tokyo
Japan	Novartis Investigative Site	Takarazuka	Hyogo
Japan	Novartis Investigative Site	Toyama-city	Toyama
Japan	Novartis Investigative Site	Ueda	Nagano
Japan	Novartis Investigative Site	Urayasu	Chiba
Japan	Novartis Investigative Site	Urayasu	Chiba
Japan	Novartis Investigative Site	Yokkaichi	Mie
Japan	Novartis Investigative Site	Yokohama	Kanagawa
Japan	Novartis Investigative Site	Yoshida-gun	Fukui
Japan	Novartis Investigative Site	Yufu	Oita

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with adverse events corresponding to each of the safety specifications during the observation period	Proportion of patients with adverse events corresponding to each of the safety specifications during the observation period is going to be collected.; Safety specifications: intraocular inflammation, endophthalmitis, intraocular pressure elevation, retinal detachment and retinal tear, retinal arterial embolic events, non-ocular arterial thromboembolic events, retinal vasculitis and retinal vascular occlusion	Up to 52 weeks
Primary	Proportions of patients with adverse events in the eyes on therapy during the observation period	Proportions of patients with adverse events in the eyes on therapy during the observation period is going to be collected	Up to 52 weeks
Primary	Proportion of patients with systemic adverse events during the observation period	Proportion of patients with systemic (non-ocular) adverse events during the observation period is going to be collected	Up to 52 weeks
Secondary	Proportion of patients with serious adverse events (SAEs) and adverse reactions in the eyes on therapy during the observation period	Proportion of patients with serious adverse events (SAEs) and adverse reactions in the eyes on therapy during the observation period is going to be collected	Up to 52 weeks
Secondary	Proportion of patients with systemic SAEs and adverse reactions during the observation period	Proportion of patients with systemic (non-ocular) SAEs and adverse reactions during the observation period is going to be collected	Up to 52 weeks
Secondary	Proportion of patients with SAEs, adverse reactions and serious adverse reactions corresponding to the safety specifications during the observation period	Proportion of patients with SAEs, adverse reactions and serious adverse reactions corresponding to the safety specifications during the observation period is going to be collected.; Safety specifications: intraocular inflammation, endophthalmitis, intraocular pressure elevation, retinal detachment and retinal tear, retinal arterial embolic events, non-ocular arterial thromboembolic events, retinal vasculitis and retinal vascular occlusion	Up to 52 weeks
Secondary	Incidences of adverse events by risk factor of the safety specifications	Incidences of adverse events by risk factor of the safety specifications (primary treated eyes only) is going to be collected.; Safety specifications: intraocular inflammation, endophthalmitis, intraocular pressure elevation, retinal detachment and retinal tear, retinal arterial embolic events, non-ocular arterial thromboembolic events, retinal vasculitis and retinal vascular occlusion	Up to 52 weeks
Secondary	Proportion of patients with VA worsening during the observation period	Proportion of patients with decimal VA worsening during the observation period will be calculated.; VA will be measured in best corrected visual acuity (BCVA). BCVA is the best possible vision that an eye can achieve with the use of glasses or contact lenses	Up to 52 weeks
Secondary	Proportion of patients by administration status in the induction and maintenance phase during the observation period	Number of patients by administration status (yes/no) in the induction and maintenance phase during the observation period will be collected	Up to 52 weeks
Secondary	Proportion of patients by treated eye in the induction and maintenance phase during the observation period	Number of patients by treated eye (right eye/left eye) in the induction and maintenance phase during the observation period will be collected	Up to 52 weeks