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

Overview

This is 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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 2, 2019

Interventions

  • Drug: RTH258
    • 6 mg in prefilled syringe

Arms, Groups and Cohorts

  • Experimental: RTH258
    • brolucizumab 6 mg in a prefilled syringe

Clinical Trial Outcome Measures

Primary Measures

  • The safety of brolucizumab 6 mg delivered in prefilled syringe in patients with neovascular age related macular degeneration
    • Time Frame: Up to Day 8
    • The safety is defined as the incidence of ocular and non-ocular adverse events

Participating in This Clinical Trial

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.

Other protocol defined inclusion and exclusion criteria may apply.

Gender Eligibility: All

Minimum Age: 50 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Novartis Pharmaceuticals
  • Provider of Information About this Clinical Study
    • Sponsor

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