A 52-weeks Observational Study to Evaluate the Safety of Brolucizumab in Patients With nAMD

Completed

• Conditions: Neovascular Age-related Macular Degeneration
• Interventions: Drug: Beovu

• Registration Number: NCT04632056
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

This study was a prospective, uncontrolled, central registration system, multicenter, domestic observational study (special drug-use surveillance) to evaluate the safety of 52-week clinical treatment with Beovu kit for intravitreal injection in nAMD patients.

Detailed Description

The observational period was 1 year (52 weeks) from the first brolucizumab administration in the primary treated eye.

However, if brolucizumab was discontinued in the primary treated eye and if the treatment was discontinued less than 52 weeks observation period, the observation period was to be up to 90 days after the last dose of this drug. This was set in order to collect data as much as possible based on the clinical effect of the drug. If 30 days after the last dose of this drug in a discontinued patient exceeds 52 weeks of the observation period, the patient was to be monitored for adverse events until 30 days after the last dose of this drug.

Study Timeline

• Study First Submitted: 2020-11-12
• Study First Submitted QC: 2020-11-12
• Study Start: 2020-11-16
• Study First Posted: 2020-11-17
• Primary Completion: 2022-11-10
• Study Completion: 2022-11-10
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-10
• Last Update Posted: 2023-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 329

Inclusion Criteria

1. Patients must provide written consent to cooperate in this study before treatment with Beovu kit for intravitreal injection

2. Patients using Beovu kit for intravitreal injection for the first time for the following indication:

   • Indication: age-related macular degeneration with subfoveal choroidal neovascularization

Read More

Exclusion Criteria

1. Patients with a history of treatment with a drug containing the same ingredient (brolucizumab; investigational drug or post-marketing clinical study drug) as Beovu kit for intravitreal injection

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Beovu	Beovu	Brolucizumab (Genetical Recombination) 6 mg (0.05 mL) was administered by intravitreal injection every 4 weeks for the first three doses(loading phase). In the following maintenance phase, Brolucizumab was basically administered every 12 weeks. The interval between treatments was adjusted as appropriate according to the symptoms. The interval between two doses was not to be shorter than 8 weeks

Primary Outcome Measures

Name	Time	Method
Number of patients with adverse events in the eyes on therapy	52 weeks	Number of patients with adverse events (AEs) in the eyes on therapy were reported
Number of patients with adverse events in other parts of the body (non-ocular)	52 weeks	Number of patients with adverse events (AEs) in other parts of the body (non-ocular) were reported

Secondary Outcome Measures

Name	Time	Method
Number of patients with SAEs and ADRs in other parts of the body (non-ocular)	52 weeks	A SAE is defined as an AE whose description suggests that it is serious or whose outcome is fatal.; An adverse reaction is defined as an adverse event that is suspected by the investigator to be causally related to Beovu or administration procedures, or whose causality is not recorded.
Number of patients with serious adverse events (SAEs) and adverse reactions (ADRs) in the eyes on therapy	52 weeks	A SAE is defined as an AE whose description suggests that it is serious or whose outcome is fatal.; An adverse reaction is defined as an adverse event that is suspected by the investigator to be causally related to Beovu or administration procedures, or whose causality is not recorded.
Number of patients with adverse events, SAEs, ADRs and serious ADRs corresponding to the safety specifications	52 weeks	The following events were chosen as the safety specifications for this study that should be investigated: * Intraocular inflammation; * Endophthalmitis; * Increased intraocular pressure; * Retinal pigment epithelial tear; * Retinal detachment and retinal tear; * Retinal artery embolic events; * Non-ocular arterial thromboembolic events; * Retinal vasculitis and retinal vascular occlusion
Incidence of adverse events by risk factor of the safety specifications (primary treated eyes only)	52 weeks	Incidence of adverse events by risk factor of the safety specifications (primary treated eyes only) were reported
Proportion of patients with visual acuity (VA) worsening	52 weeks	Visual acuity commonly refers to the clarity of vision
Data on Beovu administration in the induction phase and maintenance phase	52 weeks	For data on Beovu administration (dosing duration, dosing frequency) in the primary treated eye and the secondary primary eyes in the safety analysis set, summary statistics were calculated respectively. The same calculation applied to data on administration respectively for the induction period and the maintenance period.

Trial Locations

Locations (1)

Novartis Investigative Site; 🇯🇵 Osaka, Japan