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NCT Number: NCT03930641

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

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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Key information

Conditions

Neovascular Age Related Macular Degeneration

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novartis Investigative Site, Altamonte Springs, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

RTH258

Drug

6 mg in prefilled syringe

Other names: brolucizumab

Primary outcomes

  1. The Safety of Brolucizumab 6 mg Delivered in Prefilled Syringe in Patients With Neovascular Age Related Macular Degeneration

    Time frame: Up to Day 31

    The safety is defined as the incidence of ocular and non-ocular adverse events

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Apr 29, 2019
Registry last updated
Jan 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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