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)

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.

Study Overview

• Status: Completed
• Conditions: Neovascular Age-related Macular Degeneration
• Intervention / Treatment: Drug: Beovu

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 329

Contacts and Locations

Study Locations

• Japan
  • Akita, Japan, 010-8543
    • Novartis Investigative Site
  • Fukuoka, Japan, 814-0013
    • Novartis Investigative Site
  • Fukuoka, Japan, 814-0193
    • Novartis Investigative Site
  • Fukuoka, Japan, 819-8585
    • Novartis Investigative Site
  • Fukuoka, Japan, 814-0011
    • Novartis Investigative Site
  • Hiroshima, Japan, 731-5133
    • Novartis Investigative Site
  • Kyoto, Japan, 604-0837
    • Novartis Investigative Site
  • Nagasaki, Japan, 850-0918
    • Novartis Investigative Site
  • Okayama, Japan, 701-0153
    • Novartis Investigative Site
  • Osaka, Japan, 545-8586
    • Novartis Investigative Site
  • Aichi
    • Nagoya, Aichi, Japan, 466 8560
      • Novartis Investigative Site
    • Nagoya, Aichi, Japan, 457 8510
      • Novartis Investigative Site
    • Nagoya, Aichi, Japan, 456-0032
      • Novartis Investigative Site
    • Nagoya City, Aichi, Japan, 460-0008
      • Novartis Investigative Site
    • Nagoya-city, Aichi, Japan, 462-0825
      • Novartis Investigative Site
    • Toyohashi, Aichi, Japan, 441-8106
      • Novartis Investigative Site
  • Chiba
    • Urayasu, Chiba, Japan, 279-0021
      • Novartis Investigative Site
  • Fukuoka
    • Iizuka, Fukuoka, Japan, 820-0043
      • Novartis Investigative Site
    • Kurume city, Fukuoka, Japan, 830-0011
      • Novartis Investigative Site
  • Hiroshima
    • Kure, Hiroshima, Japan, 737-0029
      • Novartis Investigative Site
  • Hokkaido
    • Hakodat, Hokkaido, Japan, 041-0806
      • Novartis Investigative Site
    • Hakodate-city, Hokkaido, Japan, 041-0851
      • Novartis Investigative Site
    • Sapporo, Hokkaido, Japan, 060-0010
      • Novartis Investigative Site
  • Hyogo
    • Kakogawa-shi, Hyogo, Japan, 675-8611
      • Novartis Investigative Site
    • Kobe, Hyogo, Japan, 650-0047
      • Novartis Investigative Site
    • Kobe, Hyogo, Japan, 652-0863
      • Novartis Investigative Site
    • Nishinomiya, Hyogo, Japan, 663 8501
      • Novartis Investigative Site
  • Ibaraki
    • Ishioka, Ibaraki, Japan, 315-0037
      • Novartis Investigative Site
    • Mito, Ibaraki, Japan, 310-0845
      • Novartis Investigative Site
  • Ishikawa
    • Kanazawa, Ishikawa, Japan, 921-8161
      • Novartis Investigative Site
  • Kagawa
    • Kita-gun, Kagawa, Japan, 761-0793
      • Novartis Investigative Site
  • Kanagawa
    • Yokohama city, Kanagawa, Japan, 232 0024
      • Novartis Investigative Site
    • Yokosuka-city, Kanagawa, Japan, 238-8558
      • Novartis Investigative Site
  • Kumamoto
    • Kumamoto City, Kumamoto, Japan, 860-8556
      • Novartis Investigative Site
  • Mie
    • Yokkaichi, Mie, Japan, 510-8567
      • Novartis Investigative Site
  • Miyagi
    • Kesennuma, Miyagi, Japan, 988-0052
      • Novartis Investigative Site
    • Sendai, Miyagi, Japan, 980-0824
      • Novartis Investigative Site
    • Sendai city, Miyagi, Japan, 980 8574
      • Novartis Investigative Site
  • Miyazaki
    • Miyakonojo, Miyazaki, Japan, 885-0000
      • Novartis Investigative Site
  • Nagano
    • Matsumoto, Nagano, Japan, 390-8621
      • Novartis Investigative Site
  • Nagasaki
    • Nagasaki-shi, Nagasaki, Japan, 852-8511
      • Novartis Investigative Site
  • Nara
    • Kashihara city, Nara, Japan, 634 8522
      • Novartis Investigative Site
  • Okayama
    • Okayama-city, Okayama, Japan, 700-8558
      • Novartis Investigative Site
  • Okinawa
    • Nakagami, Okinawa, Japan, 903 0215
      • Novartis Investigative Site
    • Urazoe, Okinawa, Japan, 901-2133
      • Novartis Investigative Site
  • Osaka
    • Hirakata-city, Osaka, Japan, 573-1191
      • Novartis Investigative Site
    • Moriguchi, Osaka, Japan, 570-8507
      • Novartis Investigative Site
    • Osaka Sayama, Osaka, Japan, 589 8511
      • Novartis Investigative Site
    • Osaka-city, Osaka, Japan, 543-8555
      • Novartis Investigative Site
    • Sakai-city, Osaka, Japan, 593-8304
      • Novartis Investigative Site
    • Suita, Osaka, Japan, 565 0871
      • Novartis Investigative Site
  • Saitama
    • Iruma-gun, Saitama, Japan, 350-0495
      • Novartis Investigative Site
    • Saitama-shi, Saitama, Japan, 336-0963
      • Novartis Investigative Site
  • Shiga
    • Ohtsu-city, Shiga, Japan, 520-2192
      • Novartis Investigative Site
    • Ohtsu-city, Shiga, Japan, 520-0046
      • Novartis Investigative Site
  • Shimane
    • Oda, Shimane, Japan, 694-0064
      • Novartis Investigative Site
  • Shizuoka
    • Hamamatsu-city, Shizuoka, Japan, 430-8558
      • Novartis Investigative Site
    • Izunokuni, Shizuoka, Japan, 410-2295
      • Novartis Investigative Site
    • Shizuoka-City, Shizuoka, Japan, 422-8076
      • Novartis Investigative Site
  • Tochigi
    • Shimotsuke, Tochigi, Japan, 329-0498
      • Novartis Investigative Site
  • Tokyo
    • Bunkyo ku, Tokyo, Japan, 113-8431
      • Novartis Investigative Site
    • Bunkyo ku, Tokyo, Japan, 113 8655
      • Novartis Investigative Site
    • Chiyoda-ku, Tokyo, Japan, 101-8309
      • Novartis Investigative Site
    • Hachioji-city, Tokyo, Japan, 193-0944
      • Novartis Investigative Site
    • Musashino, Tokyo, Japan, 180-0006
      • Novartis Investigative Site
    • Shinjuku ku, Tokyo, Japan, 162 8666
      • Novartis Investigative Site
    • Shinjuku-ku, Tokyo, Japan, 160 8582
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 95 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients with visual acuity (VA) worsening	Visual acuity commonly refers to the clarity of vision	52 weeks
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals
• Investigators: Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2020
• Primary Completion (Actual): November 10, 2022
• Study Completion (Actual): November 10, 2022

Study Registration Dates

• First Submitted: November 12, 2020
• First Submitted That Met QC Criteria: November 12, 2020
• First Posted (Actual): November 17, 2020

Study Record Updates

• Last Update Posted (Estimated): November 14, 2023
• Last Update Submitted That Met QC Criteria: November 10, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: non-interventional study; neovascular age-related macular degeneration; Japan; brolucizumab; post-marketing surveillance; (nAMD)
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Wet Macular Degeneration
• Other Study ID Numbers: CRTH258A1401

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No