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

Phase 3

Completed

• Conditions: Neovascular Age Related Macular Degeneration
• Interventions: Drug: RTH258

• Registration Number: NCT03930641
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2019-04-26
• Study First Submitted QC: 2019-04-26
• Study First Posted: 2019-04-29
• Study Start: 2019-05-23
• Primary Completion: 2019-07-02
• Study Completion: 2019-07-02
• Results First Submitted: 2020-06-23
• Status Verified: 2020-07
• Results First Submitted QC: 2020-07-16
• Results First Posted: 2020-08-03
• Last Update Submitted: 2020-12-11
• Last Update Posted: 2021-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
RTH258	RTH258	brolucizumab 6 mg in a prefilled syringe

Primary Outcome Measures

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

Trial Locations

Locations (1)

Novartis Investigative Site; 🇺🇸 Richmond, Virginia, United States