Special Drug Use Observational Study With Beovu Kit for Intravitreal Injection

Diabetic Macular Edema Clinical Trial

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

Status Active, not recruiting

Clinical Trial Summary

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.

Clinical Trial 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 ;

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Macular Edema

• NCT number: NCT05526729
• Study type: Observational
• Source: Novartis
• Status: Active, not recruiting
• Start date: September 2, 2022
• Completion date: June 29, 2024