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

NCT ID: NCT04632056

Last Updated: 2023-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

329 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-16

Study Completion Date

2022-11-10

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Neovascular Age-related Macular Degeneration

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Beovu

Brolucizumab (Genetical Recombination) 6 mg (0.05 mL) was administered by intravitreal injection every 4 weeks for the first three doses(loading phase). In the following maintenance phase, Brolucizumab was basically administered every 12 weeks. The interval between treatments was adjusted as appropriate according to the symptoms. The interval between two doses was not to be shorter than 8 weeks

Beovu

Intervention Type DRUG

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

Interventions

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Beovu

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

Intervention Type DRUG

Other Intervention Names

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Brolucizumab

Eligibility Criteria

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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
Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Nagoya, Aichi-ken, Japan

Site Status

Novartis Investigative Site

Nagoya, Aichi-ken, Japan

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Novartis Investigative Site

Nagoya, Aichi-ken, Japan

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Novartis Investigative Site

Nagoya, Aichi-ken, Japan

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Novartis Investigative Site

Nagoya, Aichi-ken, Japan

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Toyohashi, Aichi-ken, Japan

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Novartis Investigative Site

Urayasu, Chiba, Japan

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Iizuka, Fukuoka, Japan

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Kurume, Fukuoka, Japan

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Kure, Hiroshima, Japan

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Hakodate, Hokkaido, Japan

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Hakodat, Hokkaido, Japan

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Sapporo, Hokkaido, Japan

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Kakogawa-shi, Hyōgo, Japan

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Kobe, Hyōgo, Japan

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Kobe, Hyōgo, Japan

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Nishinomiya, Hyōgo, Japan

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Ishioka, Ibaraki, Japan

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Mito, Ibaraki, Japan

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Kanazawa, Ishikawa-ken, Japan

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Kita-gun, Kagawa-ken, Japan

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Yokohama, Kanagawa, Japan

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Yokosuka, Kanagawa, Japan

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Kumamoto, Kumamoto, Japan

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Yokkaichi, Mie-ken, Japan

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Kesennuma, Miyagi, Japan

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Sendai, Miyagi, Japan

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Sendai, Miyagi, Japan

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Miyakonojō, Miyazaki, Japan

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Matsumoto, Nagano, Japan

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Nagasaki, Nagasaki, Japan

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Kashihara, Nara, Japan

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Okayama, Okayama-ken, Japan

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Nakagami, Okinawa, Japan

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Urazoe, Okinawa, Japan

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Hirakata, Osaka, Japan

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Moriguchi, Osaka, Japan

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Osaka, Osaka, Japan

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Ōsaka-sayama, Osaka, Japan

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Sakai, Osaka, Japan

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Suita, Osaka, Japan

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Iruma-gun, Saitama, Japan

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Saitama-shi, Saitama, Japan

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Ohtsu-city, Shiga, Japan

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Ohtsu-city, Shiga, Japan

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Oda, Shimane, Japan

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Hamamatsu, Shizuoka, Japan

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Izunokuni, Shizuoka, Japan

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Shizuoka, Shizuoka, Japan

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Shimotsuke, Tochigi, Japan

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Bunkyo Ku, Tokyo, Japan

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Novartis Investigative Site

Bunkyo Ku, Tokyo, Japan

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Novartis Investigative Site

Chiyoda-ku, Tokyo, Japan

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Novartis Investigative Site

Hachiōji, Tokyo, Japan

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Novartis Investigative Site

Musashino, Tokyo, Japan

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Novartis Investigative Site

Shinjuku Ku, Tokyo, Japan

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Novartis Investigative Site

Shinjuku-ku, Tokyo, Japan

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Novartis Investigative Site

Akita, , Japan

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Novartis Investigative Site

Fukuoka, , Japan

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Novartis Investigative Site

Fukuoka, , Japan

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Novartis Investigative Site

Fukuoka, , Japan

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Novartis Investigative Site

Fukuoka, , Japan

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Novartis Investigative Site

Hiroshima, , Japan

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Novartis Investigative Site

Kyoto, , Japan

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Novartis Investigative Site

Nagasaki, , Japan

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Novartis Investigative Site

Okayama, , Japan

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Novartis Investigative Site

Osaka, , Japan

Site Status

Countries

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Japan

Related Links

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https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=18111

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

Other Identifiers

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CRTH258A1401

Identifier Type: -

Identifier Source: org_study_id

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