Special Drug Use Observational Study With Beovu Kit for Intravitreal Injection

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Diabetic Macular Edema

Intervention / Treatment
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* Other: Beovu


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Beovu<br>Patients prescribed with Beovu for diabetic macular edema | Other: Beovu<br>* 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.<br>* Other names: Brolucizumab;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetic macular edema, DME, NIS, Japan, PMS, Beovu