Special Drug Use Observational Study With Beovu Kit for Intravitreal Injection
NCT ID: NCT05526729
Last Updated: 2025-06-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
222 participants
OBSERVATIONAL
2022-09-02
2024-06-29
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Post Marketing Study to Evaluate the Safety and Effectiveness of Brolucizumab in Patients With Diabetic Macular Edema.
NCT05959304
Primovist Post-marketing Surveillance in Japan
NCT01411449
Japanese Safety Study of VEGF Trap-Eye in DME (Diabetic Macular Edema)
NCT01512966
Multiple Dose Safety and Efficacy of LKA651 in Patients With Diabetic Macular Edema
NCT03927690
Safety and Efficacy Study of Conbercept in Diabetic Macular Edema (DME) (Sailing)
NCT02194634
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The observation period was 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 applied.
* 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
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Beovu
Patients prescribed with Beovu for diabetic macular edema
Beovu
Prospective observational study. There was no treatment allocation. Patients prescribed with Beovu for the first time for diabetic macular edema were eligible to enroll into this study.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Beovu
Prospective observational study. There was no treatment allocation. Patients prescribed with Beovu for the first time for diabetic macular edema were eligible to enroll into this study.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Patients using Beovu for the first time for the following indication • Indication: diabetic macular edema
Exclusion Criteria
0 Years
99 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Novartis Pharmaceuticals
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Novartis Investigative Site
Nagakute, Aichi-ken, Japan
Novartis Investigative Site
Nagoya, Aichi-ken, Japan
Novartis Investigative Site
Nagoya, Aichi-ken, Japan
Novartis Investigative Site
Nagoya, Aichi-ken, Japan
Novartis Investigative Site
Nagoya, Aichi-ken, Japan
Novartis Investigative Site
Nagoya, Aichi-ken, Japan
Novartis Investigative Site
Kashiwa, Chiba, Japan
Novartis Investigative Site
Kisarazu, Chiba, Japan
Novartis Investigative Site
Urayasu, Chiba, Japan
Novartis Investigative Site
Urayasu, Chiba, Japan
Novartis Investigative Site
Yoshida-gun, Fukui, Japan
Novartis Investigative Site
Fukuoka, Fukuoka, Japan
Novartis Investigative Site
Fukuoka, Fukuoka, Japan
Novartis Investigative Site
Kurume, Fukuoka, Japan
Novartis Investigative Site
Fukushima, Fukushima, Japan
Novartis Investigative Site
Mizunami, Gifu, Japan
Novartis Investigative Site
Maebashi, Gunma, Japan
Novartis Investigative Site
Asahikawa, Hokkaido, Japan
Novartis Investigative Site
Hakodate, Hokkaido, Japan
Novartis Investigative Site
Hakodat, Hokkaido, Japan
Novartis Investigative Site
Sapporo, Hokkaido, Japan
Novartis Investigative Site
Sapporo, Hokkaido, Japan
Novartis Investigative Site
Kobe, Hyōgo, Japan
Novartis Investigative Site
Kobe, Hyōgo, Japan
Novartis Investigative Site
Nishinomiya, Hyōgo, Japan
Novartis Investigative Site
Sumoto, Hyōgo, Japan
Novartis Investigative Site
Takarazuka, Hyōgo, Japan
Novartis Investigative Site
Inashiki, Ibaraki, Japan
Novartis Investigative Site
Ishioka, Ibaraki, Japan
Novartis Investigative Site
Mito, Ibaraki, Japan
Novartis Investigative Site
Kita-gun, Kagawa-ken, Japan
Novartis Investigative Site
Kagoshima, Kagoshima-ken, Japan
Novartis Investigative Site
Yokohama, Kanagawa, Japan
Novartis Investigative Site
Nankoku, Kochi, Japan
Novartis Investigative Site
Arao, Kumamoto, Japan
Novartis Investigative Site
Kyoto, Kyoto, Japan
Novartis Investigative Site
Yokkaichi, Mie-ken, Japan
Novartis Investigative Site
Miyakonojō, Miyazaki, Japan
Novartis Investigative Site
Matsumoto, Nagano, Japan
Novartis Investigative Site
Ueda, Nagano, Japan
Novartis Investigative Site
Nagasaki, Nagasaki, Japan
Novartis Investigative Site
Nagasaki, Nagasaki, Japan
Novartis Investigative Site
Nagasaki, Nagasaki, Japan
Novartis Investigative Site
Kashihara, Nara, Japan
Novartis Investigative Site
Jōetsu, Niigata, Japan
Novartis Investigative Site
Sanjō, Niigata, Japan
Novartis Investigative Site
Ōita, Oita Prefecture, Japan
Novartis Investigative Site
Yufu, Oita Prefecture, Japan
Novartis Investigative Site
Kurashiki, Okayama-ken, Japan
Novartis Investigative Site
Okayama, Okayama-ken, Japan
Novartis Investigative Site
Hirakata, Osaka, Japan
Novartis Investigative Site
Moriguchi, Osaka, Japan
Novartis Investigative Site
Osaka, Osaka, Japan
Novartis Investigative Site
Ōsaka-sayama, Osaka, Japan
Novartis Investigative Site
Sakai, Osaka, Japan
Novartis Investigative Site
Suita, Osaka, Japan
Novartis Investigative Site
Iruma-gun, Saitama, Japan
Novartis Investigative Site
Ohtsu, Shiga, Japan
Novartis Investigative Site
Oda, Shimane, Japan
Novartis Investigative Site
Shimotsuke, Tochigi, Japan
Novartis Investigative Site
Bunkyo Ku, Tokyo, Japan
Novartis Investigative Site
Chiyoda-ku, Tokyo, Japan
Novartis Investigative Site
Edogawa City, Tokyo, Japan
Novartis Investigative Site
Hachiōji, Tokyo, Japan
Novartis Investigative Site
Hachiōji, Tokyo, Japan
Novartis Investigative Site
Itabashi-ku, Tokyo, Japan
Novartis Investigative Site
Katsushika-ku, Tokyo, Japan
Novartis Investigative Site
Musashino, Tokyo, Japan
Novartis Investigative Site
Taito-ku, Tokyo, Japan
Novartis Investigative Site
Toyama, Toyama, Japan
Novartis Investigative Site
Akita, , Japan
Novartis Investigative Site
Kumamoto, , Japan
Novartis Investigative Site
Kyoto, , Japan
Novartis Investigative Site
Okayama, , Japan
Novartis Investigative Site
Osaka, , Japan
Novartis Investigative Site
Osaka, , Japan
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Results for CRTH258B1401 that is getting linked from the Novartis Clinical Trials Website
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CRTH258B1401
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.