Special Drug Use Observational Study With Beovu Kit for Intravitreal Injection

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

ClinicalTrials.gov Identifier: NCT05526729

Novartis Reference Number: CRTH258B1401

Last Update: Sep 28, 2022

See if you pre-qualify

All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

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.

Condition 
Diabetic Macular Edema
Phase 
Not Given
Overall status 
Recruiting
Start date 
Sep 02, 2022
Completion date 
Sep 30, 2024
Gender 
All
Age(s)
99 Years and older (Child, Adult, Older Adult)

Interventions

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.

Eligibility Criteria

Inclusion Criteria:

Patients must provide written consent to cooperate in this study before the start of treatment with Beovu
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 Locations

Japan
Novartis Investigative Site
Recruiting
Urayasu, 279-0011
Chiba
Japan
Novartis Investigative Site
Recruiting
Kure, 737-0029
Hiroshima
Japan
Novartis Investigative Site
Recruiting
Hakodate-city, 041-0851
Hokkaido
Japan
Novartis Investigative Site
Recruiting
Hakodat, 041-0806
Hokkaido
Japan
Novartis Investigative Site
Recruiting
Kobe, 652-0863
Hyogo
Japan
Novartis Investigative Site
Recruiting
Sumoto, 656-0101
Hyogo
Japan
Novartis Investigative Site
Recruiting
Arao, 864-0041
Kumamoto
Japan
Novartis Investigative Site
Recruiting
Ueda, 386-0018
Nagano
Japan
Novartis Investigative Site
Recruiting
Okayama-city, 700-0024
Okayama
Japan
Novartis Investigative Site
Recruiting
Osaka Sayama, 589 8511
Osaka
Japan
Novartis Investigative Site
Recruiting
Sakai-city, 593-8304
Osaka
Japan
Novartis Investigative Site
Recruiting
Saga-city, 840-0831
Saga
Japan
Novartis Investigative Site
Recruiting
Oda, 694-0064
Shimane
Japan
Novartis Investigative Site
Recruiting
Hachioji-city, 192-0081
Tokyo
Japan
Novartis Investigative Site
Recruiting
Itabashi-ku, 174-0053
Tokyo
Japan
Novartis Investigative Site
Recruiting
Taito-ku, 111-0051
Tokyo
Japan
Novartis Investigative Site
Recruiting
Kyoto, 604-0837
-
Japan
Novartis Investigative Site
Recruiting
Miyazaki, 880-0021
-
Japan
Novartis Investigative Site
Recruiting
Okayama, 701-0153
-
Japan

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 

Have a question?

Call 1-888-669-6682 or email [email protected]