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

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

ClinicalTrials.gov Identifier: NCT04632056

Novartis Reference Number: CRTH258A1401

Last Update: Nov 01, 2021

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

This study is 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.

Condition 
Neovascular Age-related Macular Degeneration
Phase 
Not Given
Overall status 
Recruiting
Enrollment count 
300 participants
Start date 
Nov 16, 2020
Completion date 
May 31, 2023
Gender 
All
Age(s)
99 Years and older (Child, Adult, Older Adult)

Interventions

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

Eligibility Criteria

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:

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

Study Locations

Japan
Novartis Investigative Site
Recruiting
Nagoya City, 460-0008
Aichi
Japan
Novartis Investigative Site
Recruiting
Nagoya-city, 462-0825
Aichi
Japan
Novartis Investigative Site
Recruiting
Nagoya, 456-0032
Aichi
Japan
Novartis Investigative Site
Recruiting
Nagoya, 457 8510
Aichi
Japan
Novartis Investigative Site
Recruiting
Nagoya, 466 8560
Aichi
Japan
Novartis Investigative Site
Recruiting
Toyohashi, 441-8106
Aichi
Japan
Novartis Investigative Site
Recruiting
Fukuoka city, 812-8582
Fukuoka
Japan
Novartis Investigative Site
Recruiting
Fukuoka-city,
Fukuoka
Japan
Novartis Investigative Site
Recruiting
Iizuka, 820-0043
Fukuoka
Japan
Novartis Investigative Site
Recruiting
Kurume city, 830-0011
Fukuoka
Japan
Novartis Investigative Site
Recruiting
Fukushima city, 960 1295
Fukushima
Japan
Novartis Investigative Site
Recruiting
Kure, 737-0029
Hiroshima
Japan
Novartis Investigative Site
Recruiting
Hakodate-city, 041-0851
Hokkaido
Japan
Novartis Investigative Site
Recruiting
Hakodat, 041-0806
Hokkaido
Japan
Novartis Investigative Site
Recruiting
Sapporo, 060-0010
Hokkaido
Japan
Novartis Investigative Site
Recruiting
Kakogawa-shi, 675-8611
Hyogo
Japan
Novartis Investigative Site
Recruiting
Kobe, 650-0047
Hyogo
Japan
Novartis Investigative Site
Recruiting
Kobe, 652-0863
Hyogo
Japan
Novartis Investigative Site
Recruiting
Nishinomiya, 663 8501
Hyogo
Japan
Novartis Investigative Site
Recruiting
Inashiki-gun, 300-0395
Ibaraki
Japan
Novartis Investigative Site
Recruiting
Ishioka, 315-0037
Ibaraki
Japan
Novartis Investigative Site
Recruiting
Mito-city, 310-0845
Ibaraki
Japan
Novartis Investigative Site
Recruiting
Kanazawa, 921-8161
Ishikawa
Japan
Novartis Investigative Site
Recruiting
Kita-gun, 761-0793
Kagawa
Japan
Novartis Investigative Site
Recruiting
Yokohama city, 232 0024
Kanagawa
Japan
Novartis Investigative Site
Recruiting
Yokosuka-city, 238-8558
Kanagawa
Japan
Novartis Investigative Site
Recruiting
Kumamoto City, 860-8556
Kumamoto
Japan
Novartis Investigative Site
Recruiting
Yokkaichi, 510-8567
Mie
Japan
Novartis Investigative Site
Recruiting
Kesennuma, 988-0052
Miyagi
Japan
Novartis Investigative Site
Recruiting
Sendai city, 980 8574
Miyagi
Japan
Novartis Investigative Site
Recruiting
Sendai, 980-0824
Miyagi
Japan
Novartis Investigative Site
Recruiting
Miyakonojo,
Miyazaki
Japan
Novartis Investigative Site
Recruiting
Matsumoto-city, 390-8621
Nagano
Japan
Novartis Investigative Site
Recruiting
Shiojiri, 399-0781
Nagano
Japan
Novartis Investigative Site
Recruiting
Kashihara city, 634 8522
Nara
Japan
Novartis Investigative Site
Recruiting
Okayama-city, 700-8558
Okayama
Japan
Novartis Investigative Site
Recruiting
Nakagami, 903 0215
Okinawa
Japan
Novartis Investigative Site
Recruiting
Urazoe, 901-2133
Okinawa
Japan
Novartis Investigative Site
Recruiting
Hirakata-city, 573-1191
Osaka
Japan
Novartis Investigative Site
Recruiting
Moriguchi, 570-8507
Osaka
Japan
Novartis Investigative Site
Recruiting
Osaka Sayama, 589 8511
Osaka
Japan
Novartis Investigative Site
Recruiting
Osaka-city, 530-8480
Osaka
Japan
Novartis Investigative Site
Recruiting
Osaka-city, 543-8555
Osaka
Japan
Novartis Investigative Site
Recruiting
Sakai-city, 593-8304
Osaka
Japan
Novartis Investigative Site
Recruiting
Suita city, 565 0871
Osaka
Japan
Novartis Investigative Site
Recruiting
Hanyu,
Saitama
Japan
Novartis Investigative Site
Recruiting
Iruma-gun, 350-0495
Saitama
Japan
Novartis Investigative Site
Recruiting
Saitama-shi, 336-0963
Saitama
Japan
Novartis Investigative Site
Recruiting
Ohtsu-city, 520-2192
Shiga
Japan
Novartis Investigative Site
Recruiting
Ohtsu-city,
Shiga
Japan
Novartis Investigative Site
Recruiting
Oda, 694-0064
Shimane
Japan
Novartis Investigative Site
Recruiting
Hamamatsu-city, 430-8558
Shizuoka
Japan
Novartis Investigative Site
Recruiting
Izunokuni, 410-2295
Shizuoka
Japan
Novartis Investigative Site
Recruiting
Shizuoka-City, 422-8076
Shizuoka
Japan
Novartis Investigative Site
Recruiting
Shimotsuke, 329-0498
Tochigi
Japan
Novartis Investigative Site
Recruiting
Bunkyo ku, 113 8655
Tokyo
Japan
Novartis Investigative Site
Recruiting
Bunkyo ku, 113-8431
Tokyo
Japan
Novartis Investigative Site
Recruiting
Chiyoda-ku, 101-8309
Tokyo
Japan
Novartis Investigative Site
Recruiting
Chuo ku, 104-8560
Tokyo
Japan
Novartis Investigative Site
Recruiting
Edogawa-ku, 134-0088
Tokyo
Japan
Novartis Investigative Site
Recruiting
Hachioji-city, 193-0944
Tokyo
Japan
Novartis Investigative Site
Recruiting
Musashino, 180-0006
Tokyo
Japan
Novartis Investigative Site
Recruiting
Shinjuku ku, 162 8666
Tokyo
Japan
Novartis Investigative Site
Recruiting
Shinjuku-ku, 160 8582
Tokyo
Japan
Novartis Investigative Site
Recruiting
Urayasu, 279-0021
Tokyo
Japan
Novartis Investigative Site
Recruiting
Toyama-city, 930-0194
Toyama
Japan
Novartis Investigative Site
Recruiting
Yamagata-city, 990-0051
Yamagata
Japan
Novartis Investigative Site
Recruiting
Akita, 010-8543
-
Japan
Novartis Investigative Site
Recruiting
Fukuoka, 814-0013
-
Japan
Novartis Investigative Site
Recruiting
Fukuoka, 814-0193
-
Japan
Novartis Investigative Site
Recruiting
Fukuoka, 819-8585
-
Japan
Novartis Investigative Site
Recruiting
Hiroshima, 731-5133
-
Japan
Novartis Investigative Site
Recruiting
Kyoto, 604-0837
-
Japan
Novartis Investigative Site
Recruiting
Nagasaki, 850-0918
-
Japan
Novartis Investigative Site
Recruiting
Okayama, 701-0153
-
Japan
Novartis Investigative Site
Recruiting
Osaka, 545-8586
-
Japan

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Phone: 

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