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

Novartis

Status and phase: Completed; Phase 3

Conditions: Neovascular Age Related Macular Degeneration

Treatments: Drug: RTH258

Study type: Interventional

Funder types: Industry

Identifiers

NCT03930641

CRTH258A2308

Details and patient eligibility

About

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.

Full 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.

Enrollment: 34 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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34 participants in 1 patient group

RTH258

Experimental group

Description:

brolucizumab 6 mg in a prefilled syringe

Treatment:

Drug: RTH258