Study of the Safety of Brolucizumab 6 mg in Prefilled Syringe in Patients With Neovascular Age Related Macular Degeneration

Study Overview
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Brief Summary
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This was a multicenter, open label study that is designed to evaluate the safety of brolucizumab 6 mg in a prefilled syringe in subjects with neovascular age related macular degeneration and to support collection of observations of the prefilled syringe use for intravitreal injection.

Detailed Description
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The primary objective of this study was to evaluate the safety of brolucizumab 6 mg delivered in a pre-filled syringe (PFS) in subjects with neovascular age-related macular degeneration (nAMD) with the primary endpoint being the incidence of ocular and non-ocular adverse events (AEs). There were no other objectives for this study.

Official Title
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An Open-Label, Single-Arm, Multicenter, Phase IIIb Study in Patients With Neovascular Age-Related Macular Degeneration to Evaluate the Safety of Brolucizumab 6 mg in Prefilled Syringe

Conditions
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Neovascular Age Related Macular Degeneration

Intervention / Treatment
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* Drug: RTH258


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent must be obtained before any assessment is performed. Study eye is diagnosed with neovascular age related macular degeneration and would need an intravitreal injection. Subjects >= 50 years of age. Exclusion Criteria: Active infection or inflammation in the eyes. Uncontrolled glaucoma. History of a medical, ocular or non-ocular conditions, resulting in that the study medication cannot be safely administered. Treatment with anti-VEGF intravitreal injection in the study eye within one month prior to enrollment. The use of intraocular corticosteroids in the study eye within the last three months prior to enrollment. Recent intraocular surgery, prior long-acting therapeutic agent, or ocular drug release device implantation. Uncontrolled hypertension. Other protocol defined inclusion and exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 50 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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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: study with a single arm: brolucizumab 6 mg PFS
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RTH258<br>brolucizumab 6 mg in a prefilled syringe | Drug: RTH258<br>* 6 mg in prefilled syringe<br>* Other names: brolucizumab;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Safety of Brolucizumab 6 mg Delivered in Prefilled Syringe in Patients With Neovascular Age Related Macular Degeneration | The safety is defined as the incidence of ocular and non-ocular adverse events | Up to Day 31 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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brolucizumab 6 mg prefilled syringe PFS, open label study, neovascular age related macular degeneration intravitreal injection IVT, observation