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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05526729
Other study ID # CRTH258B1401
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date September 2, 2022
Est. completion date June 29, 2024

Study information

Verified date May 2024
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

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.


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


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Study Design


Related Conditions & MeSH terms


Intervention

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.

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Sponsors (1)

Lead Sponsor Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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