Trials / Completed
CompletedNCT03930641
Study of the Safety of Brolucizumab 6 mg in Prefilled Syringe in Patients With Neovascular Age Related Macular Degeneration
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 34 (actual)
- Sponsor
- Novartis Pharmaceuticals · Industry
- Sex
- All
- Age
- 50 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | RTH258 | 6 mg in prefilled syringe |
Timeline
- Start date
- 2019-05-23
- Primary completion
- 2019-07-02
- Completion
- 2019-07-02
- First posted
- 2019-04-29
- Last updated
- 2021-01-05
- Results posted
- 2020-08-03
Locations
3 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03930641. Inclusion in this directory is not an endorsement.