Special Drug Use Observational Study With Beovu Kit for Intravitreal Injection

Novartis

Status: Completed

Conditions: Diabetic Macular Edema

Treatments: Other: Beovu

Study type: Observational

Funder types: Industry

Identifiers

NCT05526729

CRTH258B1401

Details and patient eligibility

About

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

Full description

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

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

Enrollment: 222 patients

Sex: All

Ages: Under 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

222 participants in 1 patient group

Beovu

Description:

Patients prescribed with Beovu for diabetic macular edema

Treatment:

Other: Beovu