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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-23

Study Completion Date

2019-07-02

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.

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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.

Conditions

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Neovascular Age Related Macular Degeneration

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

study with a single arm: brolucizumab 6 mg PFS

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

open label study

Study Groups

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RTH258

brolucizumab 6 mg in a prefilled syringe

Group Type EXPERIMENTAL

RTH258

Intervention Type DRUG

6 mg in prefilled syringe

Interventions

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RTH258

6 mg in prefilled syringe

Intervention Type DRUG

Other Intervention Names

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brolucizumab

Eligibility Criteria

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Inclusion Criteria

1. Written informed consent must be obtained before any assessment is performed.
2. Study eye is diagnosed with neovascular age related macular degeneration and would need an intravitreal injection.
3. Subjects \>= 50 years of age.

Exclusion Criteria

1. Active infection or inflammation in the eyes.
2. Uncontrolled glaucoma.
3. History of a medical, ocular or non-ocular conditions, resulting in that the study medication cannot be safely administered.
4. Treatment with anti-VEGF intravitreal injection in the study eye within one month prior to enrollment.
5. The use of intraocular corticosteroids in the study eye within the last three months prior to enrollment.
6. Recent intraocular surgery, prior long-acting therapeutic agent, or ocular drug release device implantation.
7. Uncontrolled hypertension.

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No