Special Drug Use Observational Study With Beovu Kit for Intravitreal Injection

Completed

• Conditions: Diabetic Macular Edema
• Interventions: Other: Beovu

• Registration Number: NCT05526729
• Lead Sponsor: Novartis Pharmaceuticals

Brief 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.

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 Timeline

• Study First Submitted: 2022-08-31
• Study First Submitted QC: 2022-08-31
• Study Start: 2022-09-02
• Study First Posted: 2022-09-02
• Primary Completion: 2024-06-29
• Study Completion: 2024-06-29
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-12
• Last Update Posted: 2024-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 222

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Beovu	Beovu	Patients prescribed with Beovu for diabetic macular edema

Primary Outcome Measures

Name	Time	Method
Proportion of patients with adverse events corresponding to each of the safety specifications during the observation period	Up to 52 weeks	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
Proportions of patients with adverse events in the eyes on therapy during the observation period	Up to 52 weeks	Proportions of patients with adverse events in the eyes on therapy during the observation period is going to be collected
Proportion of patients with systemic adverse events during the observation period	Up to 52 weeks	Proportion of patients with systemic (non-ocular) adverse events during the observation period is going to be collected

Secondary Outcome Measures

Name	Time	Method
Proportion of patients by administration status in the induction and maintenance phase during the observation period	Up to 52 weeks	Number of patients by administration status (yes/no) in the induction and maintenance phase during the observation period will be collected
Proportion of patients with systemic SAEs and adverse reactions during the observation period	Up to 52 weeks	Proportion of patients with systemic (non-ocular) SAEs and adverse reactions during the observation period is going to be collected
Proportion of patients with VA worsening during the observation period	Up to 52 weeks	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
Proportion of patients by treated eye in the induction and maintenance phase during the observation period	Up to 52 weeks	Number of patients by treated eye (right eye/left eye) in the induction and maintenance phase during the observation period will be collected
Proportion of patients with serious adverse events (SAEs) and adverse reactions in the eyes on therapy during the observation period	Up to 52 weeks	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
Proportion of patients with SAEs, adverse reactions and serious adverse reactions corresponding to the safety specifications during the observation period	Up to 52 weeks	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
Incidences of adverse events by risk factor of the safety specifications	Up to 52 weeks	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

Trial Locations

Locations (1)

Novartis Investigative Site; 🇯🇵 Osaka, Japan