A 52-weeks Observational Study to Evaluate the Safety of Brolucizumab in Patients With nAMD

Neovascular Age-related Macular Degeneration Clinical Trial

Official title:

A 52-weeks Observational Study to Evaluate the Safety of Brolucizumab (6mg) in Patients With Neovascular Age-related Macular Degeneration (nAMD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04632056
• Other study ID #: CRTH258A1401
• Status: Completed
• Start date: November 16, 2020
• Est. completion date: November 10, 2022

Study information

• Verified date: November 2023
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 329
• Est. completion date: November 10, 2022
• Est. primary completion date: November 10, 2022
• 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 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

Related Conditions & MeSH terms

• Macular Degeneration
• Neovascular Age-related Macular Degeneration
• Wet Macular Degeneration

Intervention

Drug:
• Beovu
There is no treatment allocation. Patients administered Beovu by prescription that have started before inclusion of the patient into the study were enrolled.

Locations

Country	Name	City	State
Japan	Novartis Investigative Site	Akita
Japan	Novartis Investigative Site	Bunkyo ku	Tokyo
Japan	Novartis Investigative Site	Bunkyo ku	Tokyo
Japan	Novartis Investigative Site	Chiyoda-ku	Tokyo
Japan	Novartis Investigative Site	Fukuoka
Japan	Novartis Investigative Site	Fukuoka
Japan	Novartis Investigative Site	Fukuoka
Japan	Novartis Investigative Site	Fukuoka
Japan	Novartis Investigative Site	Hachioji-city	Tokyo
Japan	Novartis Investigative Site	Hakodat	Hokkaido
Japan	Novartis Investigative Site	Hakodate-city	Hokkaido
Japan	Novartis Investigative Site	Hamamatsu-city	Shizuoka
Japan	Novartis Investigative Site	Hirakata-city	Osaka
Japan	Novartis Investigative Site	Hiroshima
Japan	Novartis Investigative Site	Iizuka	Fukuoka
Japan	Novartis Investigative Site	Iruma-gun	Saitama
Japan	Novartis Investigative Site	Ishioka	Ibaraki
Japan	Novartis Investigative Site	Izunokuni	Shizuoka
Japan	Novartis Investigative Site	Kakogawa-shi	Hyogo
Japan	Novartis Investigative Site	Kanazawa	Ishikawa
Japan	Novartis Investigative Site	Kashihara city	Nara
Japan	Novartis Investigative Site	Kesennuma	Miyagi
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	Kure	Hiroshima
Japan	Novartis Investigative Site	Kurume city	Fukuoka
Japan	Novartis Investigative Site	Kyoto
Japan	Novartis Investigative Site	Matsumoto	Nagano
Japan	Novartis Investigative Site	Mito	Ibaraki
Japan	Novartis Investigative Site	Miyakonojo	Miyazaki
Japan	Novartis Investigative Site	Moriguchi	Osaka
Japan	Novartis Investigative Site	Musashino	Tokyo
Japan	Novartis Investigative Site	Nagasaki
Japan	Novartis Investigative Site	Nagasaki-shi	Nagasaki
Japan	Novartis Investigative Site	Nagoya	Aichi
Japan	Novartis Investigative Site	Nagoya	Aichi
Japan	Novartis Investigative Site	Nagoya	Aichi
Japan	Novartis Investigative Site	Nagoya City	Aichi
Japan	Novartis Investigative Site	Nagoya-city	Aichi
Japan	Novartis Investigative Site	Nakagami	Okinawa
Japan	Novartis Investigative Site	Nishinomiya	Hyogo
Japan	Novartis Investigative Site	Oda	Shimane
Japan	Novartis Investigative Site	Ohtsu-city	Shiga
Japan	Novartis Investigative Site	Ohtsu-city	Shiga
Japan	Novartis Investigative Site	Okayama
Japan	Novartis Investigative Site	Okayama-city	Okayama
Japan	Novartis Investigative Site	Osaka
Japan	Novartis Investigative Site	Osaka Sayama	Osaka
Japan	Novartis Investigative Site	Osaka-city	Osaka
Japan	Novartis Investigative Site	Saitama-shi	Saitama
Japan	Novartis Investigative Site	Sakai-city	Osaka
Japan	Novartis Investigative Site	Sapporo	Hokkaido
Japan	Novartis Investigative Site	Sendai	Miyagi
Japan	Novartis Investigative Site	Sendai city	Miyagi
Japan	Novartis Investigative Site	Shimotsuke	Tochigi
Japan	Novartis Investigative Site	Shinjuku ku	Tokyo
Japan	Novartis Investigative Site	Shinjuku-ku	Tokyo
Japan	Novartis Investigative Site	Shizuoka-City	Shizuoka
Japan	Novartis Investigative Site	Suita	Osaka
Japan	Novartis Investigative Site	Toyohashi	Aichi
Japan	Novartis Investigative Site	Urayasu	Chiba
Japan	Novartis Investigative Site	Urazoe	Okinawa
Japan	Novartis Investigative Site	Yokkaichi	Mie
Japan	Novartis Investigative Site	Yokohama city	Kanagawa
Japan	Novartis Investigative Site	Yokosuka-city	Kanagawa

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	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
Secondary	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
Secondary	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	52 weeks
Secondary	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
Secondary	Proportion of patients with visual acuity (VA) worsening	Visual acuity commonly refers to the clarity of vision	52 weeks
Secondary	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

External Links

•   Results for CRTH258A1401 that is getting linked from the Novartis Clinical Trials Website