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

Neovascular Age Related Macular Degeneration Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03930641
• Other study ID #: CRTH258A2308
• Status: Completed
• Phase: Phase 3
• Start date: May 23, 2019
• Est. completion date: July 2, 2019

Study information

• Verified date: July 2020
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: July 2, 2019
• Est. primary completion date: July 2, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Macular Degeneration
• Neovascular Age Related Macular Degeneration
• Wet Macular Degeneration

Intervention

Drug:
• RTH258
6 mg in prefilled syringe

Locations

Country	Name	City	State
United States	Novartis Investigative Site	Altamonte Springs	Florida
United States	Novartis Investigative Site	Pensacola	Florida
United States	Novartis Investigative Site	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   A Plain Language Trial Summary is available on novartisclinicaltrials.com