Special Drug Use Observational Study With Beovu Kit for Intravitreal Injection

Special Drug Use Observational Study With Beovu Kit for Intravitreal Injection (DME, CRTH258B1401)

This is a primary data collection-based observational special drug-use surveillance to be conducted in accordance with the Good Post-marketing Study Practice (GPSP) ordinance.

Study Overview

• Status: Active, not recruiting
• Conditions: Diabetic Macular Edema
• Intervention / Treatment: Other: Beovu

Detailed Description

This study aims to evaluate the safety of Beovu kit for intravitreal injection in clinical use in diabetic macular edema (DME) patients.

The observation period is 1 year (52 weeks) from the first Beovu administration in the primary treated eye.

In patients discontinuing treatment with Beovu in the primary treated eye before Week 52, the following observation periods will apply.

• Date of last Beovu dose + 90 days* in primary treated eye > Week 52: up to Week 52
• Date of last Beovu dose + 90 days* in primary treated eye ≤ Week 52: up to last dosing date in the primary treated eye + 90 days *90 days: to collect as much data as possible considering clinical effects

• Study Type: Observational
• Enrollment (Actual): 222

Contacts and Locations

• Study Contact: Name: Novartis Pharmaceuticals
• Study Contact Backup: Name: Novartis Pharmaceuticals; Phone Number: +81337978748; Email: novartis.email@novartis.com

Study Locations

• Japan
  • Akita, Japan, 010-8543
    • Novartis Investigative Site
  • Fukuoka, Japan, 810-8563
    • Novartis Investigative Site
  • Kyoto, Japan, 604-0837
    • Novartis Investigative Site
  • Kyoto, Japan, 606-8397
    • Novartis Investigative Site
  • Nagasaki, Japan, 852-8055
    • Novartis Investigative Site
  • Oita, Japan, 870-0852
    • Novartis Investigative Site
  • Okayama, Japan, 701-0153
    • Novartis Investigative Site
  • Osaka, Japan, 545-8586
    • Novartis Investigative Site
  • Osaka, Japan, 543-0027
    • Novartis Investigative Site
  • Osaka, Japan, 533-0024
    • Novartis Investigative Site
  • Aichi
    • Nagakute-city, Aichi, Japan, 480-1195
      • Novartis Investigative Site
    • Nagoya, Aichi, Japan, 457 8510
      • Novartis Investigative Site
    • Nagoya City, Aichi, Japan, 460-0008
      • Novartis Investigative Site
    • Nagoya-city, Aichi, Japan, 467-8602
      • Novartis Investigative Site
    • Nagoya-city, Aichi, Japan, 462-0825
      • Novartis Investigative Site
    • Nagoya-city, Aichi, Japan, 466-8650
      • Novartis Investigative Site
  • Chiba
    • Kashiwa, Chiba, Japan, 277-0004
      • Novartis Investigative Site
    • Kisarazu, Chiba, Japan, 292-8535
      • Novartis Investigative Site
    • Urayasu, Chiba, Japan, 279-0011
      • Novartis Investigative Site
    • Urayasu, Chiba, Japan, 279-0021
      • Novartis Investigative Site
  • Fukui
    • Yoshida-gun, Fukui, Japan, 910-1193
      • Novartis Investigative Site
  • Fukuoka
    • Fukuoka city, Fukuoka, Japan, 812-8582
      • Novartis Investigative Site
    • Kurume city, Fukuoka, Japan, 830-0011
      • Novartis Investigative Site
  • Fukushima
    • Fukushima city, Fukushima, Japan, 960 1295
      • Novartis Investigative Site
  • Gifu
    • Mizunami, Gifu, Japan, 509-6108
      • Novartis Investigative Site
  • Gunma
    • Maebashi city, Gunma, Japan, 371 8511
      • Novartis Investigative Site
  • Hokkaido
    • Asahikawa-city, Hokkaido, Japan, 078-8510
      • Novartis Investigative Site
    • Hakodat, Hokkaido, Japan, 041-0806
      • Novartis Investigative Site
    • Hakodate-city, Hokkaido, Japan, 041-0851
      • Novartis Investigative Site
    • Sapporo, Hokkaido, Japan, 060-8604
      • Novartis Investigative Site
    • Sapporo city, Hokkaido, Japan, 060 8648
      • Novartis Investigative Site
  • Hyogo
    • Kobe, Hyogo, Japan, 650-0047
      • Novartis Investigative Site
    • Kobe, Hyogo, Japan, 652-0863
      • Novartis Investigative Site
    • Nishinomiya-city, Hyogo, Japan, 662-0918
      • Novartis Investigative Site
    • Sumoto, Hyogo, Japan, 656-0101
      • Novartis Investigative Site
    • Takarazuka, Hyogo, Japan, 665-0061
      • Novartis Investigative Site
  • Ibaraki
    • Inashiki-gun, Ibaraki, Japan, 300-0395
      • Novartis Investigative Site
    • Ishioka, Ibaraki, Japan, 315-0037
      • Novartis Investigative Site
    • Mito, Ibaraki, Japan, 310-0845
      • Novartis Investigative Site
  • Kagawa
    • Kita-gun, Kagawa, Japan, 761-0793
      • Novartis Investigative Site
  • Kagoshima
    • Kagoshima city, Kagoshima, Japan, 890 8520
      • Novartis Investigative Site
  • Kanagawa
    • Yokohama, Kanagawa, Japan, 245-0006
      • Novartis Investigative Site
  • Kochi
    • Nankoku city, Kochi, Japan, 783 8505
      • Novartis Investigative Site
  • Kumamoto
    • Arao, Kumamoto, Japan, 864-0041
      • Novartis Investigative Site
    • Kumamoto City, Kumamoto, Japan, 860-8556
      • Novartis Investigative Site
  • Mie
    • Yokkaichi, Mie, Japan, 510-8567
      • Novartis Investigative Site
  • Miyazaki
    • Miyakonojo, Miyazaki, Japan, 885-0000
      • Novartis Investigative Site
  • Nagano
    • Matsumoto, Nagano, Japan, 390-8621
      • Novartis Investigative Site
    • Ueda, Nagano, Japan, 386-0018
      • Novartis Investigative Site
  • Nagasaki
    • Nagasaki-city, Nagasaki, Japan, 852-8501
      • Novartis Investigative Site
    • Nagasaki-shi, Nagasaki, Japan, 852-8511
      • Novartis Investigative Site
  • Nara
    • Kashihara city, Nara, Japan, 634 8522
      • Novartis Investigative Site
  • Niigata
    • Joetsu-City, Niigata, Japan, 943-0832
      • Novartis Investigative Site
    • Sanjo, Niigata, Japan, 955-0852
      • Novartis Investigative Site
  • Oita
    • Yufu, Oita, Japan, 879-5593
      • Novartis Investigative Site
  • Okayama
    • Kurashiki-city, Okayama, Japan, 710-8602
      • Novartis Investigative Site
    • Okayama-city, Okayama, Japan, 700-0024
      • 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
    • 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
  • Shiga
    • Ohtsu-city, Shiga, Japan, 520-2192
      • Novartis Investigative Site
  • Shimane
    • Oda, Shimane, Japan, 694-0064
      • Novartis Investigative Site
  • Tochigi
    • Shimotsuke, Tochigi, Japan, 329-0498
      • Novartis Investigative Site
  • Tokyo
    • Bunkyo ku, Tokyo, Japan, 113 8655
      • Novartis Investigative Site
    • Chiyoda-ku, Tokyo, Japan, 101-8309
      • Novartis Investigative Site
    • Edogawa, Tokyo, Japan, 134-0088
      • Novartis Investigative Site
    • Hachioji-city, Tokyo, Japan, 193-0944
      • Novartis Investigative Site
    • Hachioji-city, Tokyo, Japan, 192-0081
      • Novartis Investigative Site
    • Itabashi-ku, Tokyo, Japan, 174-0053
      • Novartis Investigative Site
    • Katsushika-ku, Tokyo, Japan, 125-8506
      • Novartis Investigative Site
    • Musashino, Tokyo, Japan, 180-0023
      • Novartis Investigative Site
    • Taito-ku, Tokyo, Japan, 111-0051
      • Novartis Investigative Site
  • Toyama
    • Toyama-city, Toyama, Japan, 930-0194
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 99 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients using Beovu for the first time for diabetic macular edema in Japan

Description

Inclusion Criteria:

1. Patients must provide written consent to cooperate in this study before the start of treatment with Beovu
2. Patients using Beovu for the first time for the following indication • Indication: diabetic macular edema

Exclusion Criteria:

1. Patients with a history of treatment with a drug containing the same ingredient (brolucizumab) as Beovu

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; Patients prescribed with Beovu for diabetic macular edema	Other: Beovu; Prospective observational study. There is no treatment allocation. Patients prescribed with Beovu for the first time for diabetic macular edema are eligible to enroll into this study.; Other Names: Brolucizumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients with adverse events corresponding to each of the safety specifications during the observation period	Proportion of patients with adverse events corresponding to each of the safety specifications during the observation period is going to be collected. Safety specifications: intraocular inflammation, endophthalmitis, intraocular pressure elevation, retinal detachment and retinal tear, retinal arterial embolic events, non-ocular arterial thromboembolic events, retinal vasculitis and retinal vascular occlusion	Up to 52 weeks
Proportions of patients with adverse events in the eyes on therapy during the observation period	Proportions of patients with adverse events in the eyes on therapy during the observation period is going to be collected	Up to 52 weeks
Proportion of patients with systemic adverse events during the observation period	Proportion of patients with systemic (non-ocular) adverse events during the observation period is going to be collected	Up to 52 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients with serious adverse events (SAEs) and adverse reactions in the eyes on therapy during the observation period	Proportion of patients with serious adverse events (SAEs) and adverse reactions in the eyes on therapy during the observation period is going to be collected	Up to 52 weeks
Proportion of patients with systemic SAEs and adverse reactions during the observation period	Proportion of patients with systemic (non-ocular) SAEs and adverse reactions during the observation period is going to be collected	Up to 52 weeks
Proportion of patients with SAEs, adverse reactions and serious adverse reactions corresponding to the safety specifications during the observation period	Proportion of patients with SAEs, adverse reactions and serious adverse reactions corresponding to the safety specifications during the observation period is going to be collected. Safety specifications: intraocular inflammation, endophthalmitis, intraocular pressure elevation, retinal detachment and retinal tear, retinal arterial embolic events, non-ocular arterial thromboembolic events, retinal vasculitis and retinal vascular occlusion	Up to 52 weeks
Incidences of adverse events by risk factor of the safety specifications	Incidences of adverse events by risk factor of the safety specifications (primary treated eyes only) is going to be collected. Safety specifications: intraocular inflammation, endophthalmitis, intraocular pressure elevation, retinal detachment and retinal tear, retinal arterial embolic events, non-ocular arterial thromboembolic events, retinal vasculitis and retinal vascular occlusion	Up to 52 weeks
Proportion of patients with VA worsening during the observation period	Proportion of patients with decimal VA worsening during the observation period will be calculated. VA will be measured in best corrected visual acuity (BCVA). BCVA is the best possible vision that an eye can achieve with the use of glasses or contact lenses	Up to 52 weeks
Proportion of patients by administration status in the induction and maintenance phase during the observation period	Number of patients by administration status (yes/no) in the induction and maintenance phase during the observation period will be collected	Up to 52 weeks
Proportion of patients by treated eye in the induction and maintenance phase during the observation period	Number of patients by treated eye (right eye/left eye) in the induction and maintenance phase during the observation period will be collected	Up to 52 weeks

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): September 2, 2022
• Primary Completion (Estimated): June 29, 2024
• Study Completion (Estimated): June 29, 2024

Study Registration Dates

• First Submitted: August 31, 2022
• First Submitted That Met QC Criteria: August 31, 2022
• First Posted (Actual): September 2, 2022

Study Record Updates

• Last Update Posted (Estimated): April 15, 2024
• Last Update Submitted That Met QC Criteria: April 12, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: diabetic macular edema; NIS; Japan; PMS; DME; Beovu
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Macular Edema
• Other Study ID Numbers: CRTH258B1401

Plan for Individual participant data (IPD)

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