Trials / Recruiting
RecruitingNCT04985487
Regulatory Post-Marketing Surveillance Study for Brolucizumab
Regulatory Post-Marketing Surveillance (rPMS) Study for Brolucizumab(Beovu ® Injection, Beovu ®Prefilled Syringe)
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 3,000 (estimated)
- Sponsor
- Novartis Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years – 100 Years
- Healthy volunteers
- Not accepted
Summary
This study is an open-label, multicenter, single-arm, observational post-marketing surveillance.
Detailed description
The investigators will collect safety information and evaluate effectiveness in patients who are prescribed Beovu ® Injection, Beovu ®Prefilled Syringe (brolucizumab) in the approved indication after receiving informed consent over a period of 12 weeks. In addition, longer-term data (24 weeks, optionally 36 weeks) will be collected.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | brolucizumab | Prospective observational study. There is no treatment allocation. Patients administered brolucizumab, that have started before inclusion of the patient into the study will be enrolled. |
Timeline
- Start date
- 2021-08-18
- Primary completion
- 2026-06-14
- Completion
- 2026-06-14
- First posted
- 2021-08-02
- Last updated
- 2025-01-14
Locations
28 sites across 1 country: South Korea
Source: ClinicalTrials.gov record NCT04985487. Inclusion in this directory is not an endorsement.