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

NCT04632056 | Completed

• 1 other identifier: CRTH258A1401
• Study Type: observational
• Target: 329
• Locations: 1 country
• Sites: 67

Brief 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.

Conditions

Neovascular Age-related Macular Degeneration

Keywords

Japan; brolucizumab; neovascular age-related macular degeneration; (nAMD); non-interventional study; post-marketing surveillance

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (6)

• Number of patients with serious adverse events (SAEs) and adverse reactions (ADRs) in the eyes on therapy

  52 weeks

• Number of patients with SAEs and ADRs in other parts of the body (non-ocular)

  52 weeks

• Number of patients with adverse events, SAEs, ADRs and serious ADRs corresponding to the safety specifications

  52 weeks

• Incidence of adverse events by risk factor of the safety specifications (primary treated eyes only)

  52 weeks

• Proportion of patients with visual acuity (VA) worsening

  52 weeks

Study Arms (1)

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

Drug: Beovu

Interventions

Beovu DRUG

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

Also known as: Brolucizumab

Beovu

Eligibility Criteria

• Age: Up to 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The population was patients using Beovu kit for intravitreal injection for nAMD with subfoveal CNV

You may qualify if:

• 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

You may not qualify if:

• \. 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (67)

Novartis Investigative Site

Nagoya, Aichi-ken, 456-0032, Japan

Location

Novartis Investigative Site

Nagoya, Aichi-ken, 457 8510, Japan

Location

Novartis Investigative Site

Nagoya, Aichi-ken, 460-0008, Japan

Location

Novartis Investigative Site

Nagoya, Aichi-ken, 462-0825, Japan

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Novartis Investigative Site

Nagoya, Aichi-ken, 466 8560, Japan

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Novartis Investigative Site

Toyohashi, Aichi-ken, 441-8106, Japan

Location

Novartis Investigative Site

Urayasu, Chiba, 279-0021, Japan

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Novartis Investigative Site

Iizuka, Fukuoka, 820-0043, Japan

Location

Novartis Investigative Site

Kurume, Fukuoka, 830-0011, Japan

Location

Novartis Investigative Site

Kure, Hiroshima, 737-0029, Japan

Location

Novartis Investigative Site

Hakodate, Hokkaido, 041-0851, Japan

Location

Novartis Investigative Site

Hakodat, Hokkaido, 041-0806, Japan

Location

Novartis Investigative Site

Sapporo, Hokkaido, 060-0010, Japan

Location

Novartis Investigative Site

Kakogawa-shi, Hyōgo, 675-8611, Japan

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Novartis Investigative Site

Kobe, Hyōgo, 650-0047, Japan

Location

Novartis Investigative Site

Kobe, Hyōgo, 652-0863, Japan

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Novartis Investigative Site

Nishinomiya, Hyōgo, 663 8501, Japan

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Novartis Investigative Site

Ishioka, Ibaraki, 315-0037, Japan

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Novartis Investigative Site

Mito, Ibaraki, 310-0845, Japan

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Novartis Investigative Site

Kanazawa, Ishikawa-ken, 921-8161, Japan

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Novartis Investigative Site

Kita-gun, Kagawa-ken, 761-0793, Japan

Location

Novartis Investigative Site

Yokohama, Kanagawa, 232 0024, Japan

Location

Novartis Investigative Site

Yokosuka, Kanagawa, 238-8558, Japan

Location

Novartis Investigative Site

Kumamoto, Kumamoto, 860-8556, Japan

Location

Novartis Investigative Site

Yokkaichi, Mie-ken, 510-8567, Japan

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Novartis Investigative Site

Kesennuma, Miyagi, 988-0052, Japan

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Novartis Investigative Site

Sendai, Miyagi, 980 8574, Japan

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Novartis Investigative Site

Sendai, Miyagi, 980-0824, Japan

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Novartis Investigative Site

Miyakonojō, Miyazaki, 885-0000, Japan

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Novartis Investigative Site

Matsumoto, Nagano, 390-8621, Japan

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Novartis Investigative Site

Nagasaki, Nagasaki, 852-8511, Japan

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Novartis Investigative Site

Kashihara, Nara, 634 8522, Japan

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Novartis Investigative Site

Okayama, Okayama-ken, 700-8558, Japan

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Novartis Investigative Site

Nakagami, Okinawa, 903 0215, Japan

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Novartis Investigative Site

Urazoe, Okinawa, 901-2133, Japan

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Novartis Investigative Site

Hirakata, Osaka, 573-1191, Japan

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Novartis Investigative Site

Moriguchi, Osaka, 570-8507, Japan

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Novartis Investigative Site

Osaka, Osaka, 543-8555, Japan

Location

Novartis Investigative Site

Ōsaka-sayama, Osaka, 589 8511, Japan

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Novartis Investigative Site

Sakai, Osaka, 593-8304, Japan

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Novartis Investigative Site

Suita, Osaka, 565 0871, Japan

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Novartis Investigative Site

Iruma-gun, Saitama, 350-0495, Japan

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Novartis Investigative Site

Saitama-shi, Saitama, 336-0963, Japan

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Novartis Investigative Site

Ohtsu-city, Shiga, 520-0046, Japan

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Novartis Investigative Site

Ohtsu-city, Shiga, 520-2192, Japan

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Novartis Investigative Site

Oda, Shimane, 694-0064, Japan

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Novartis Investigative Site

Hamamatsu, Shizuoka, 430-8558, Japan

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Novartis Investigative Site

Izunokuni, Shizuoka, 410-2295, Japan

Location

Novartis Investigative Site

Shizuoka, Shizuoka, 422-8076, Japan

Location

Novartis Investigative Site

Shimotsuke, Tochigi, 329-0498, Japan

Location

Novartis Investigative Site

Bunkyo Ku, Tokyo, 113 8655, Japan

Location

Novartis Investigative Site

Bunkyo Ku, Tokyo, 113-8431, Japan

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Novartis Investigative Site

Chiyoda-ku, Tokyo, 101-8309, Japan

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Novartis Investigative Site

Hachiōji, Tokyo, 193-0944, Japan

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Novartis Investigative Site

Musashino, Tokyo, 180-0006, Japan

Location

Novartis Investigative Site

Shinjuku Ku, Tokyo, 162 8666, Japan

Location

Novartis Investigative Site

Shinjuku-ku, Tokyo, 160 8582, Japan

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Novartis Investigative Site

Akita, 010-8543, Japan

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Novartis Investigative Site

Fukuoka, 814-0011, Japan

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Novartis Investigative Site

Fukuoka, 814-0013, Japan

Location

Novartis Investigative Site

Fukuoka, 814-0193, Japan

Location

Novartis Investigative Site

Fukuoka, 819-8585, Japan

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Novartis Investigative Site

Hiroshima, 731-5133, Japan

Location

Novartis Investigative Site

Kyoto, 604-0837, Japan

Location

Novartis Investigative Site

Nagasaki, 850-0918, Japan

Location

Novartis Investigative Site

Okayama, 701-0153, Japan

Location

Novartis Investigative Site

Osaka, 545-8586, Japan

Location

Related Links

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

MeSH Terms

Interventions

brolucizumab

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2020
• First Posted: November 17, 2020
• Study Start: November 16, 2020
• Primary Completion: November 10, 2022
• Study Completion: November 10, 2022
• Last Updated: November 14, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

JP (67)