Monitoring the safety and effectiveness of Beovu for eye disease
Regulatory Post-Marketing Surveillance (rPMS) Study for Brolucizumab(Beovu ® Injection, Beovu ®Prefilled Syringe)
This study is testing how safe and effective Beovu is for people with neovascular age-related macular degeneration over a 12-week period.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 3000 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Novartis Industry-sponsored |
| Drugs / interventions | Brolucizumab |
| Locations | 28 sites (Daegu, Dalseo Gu and 27 other locations) |
| Trial ID | NCT04985487 on ClinicalTrials.gov |
What this trial studies
This observational study aims to collect safety and effectiveness data on patients prescribed Beovu (brolucizumab) for neovascular age-related macular degeneration (nAMD). It will involve an open-label, multicenter, single-arm design, where participants will be monitored over a period of 12 weeks, with optional longer-term follow-up at 24 to 36 weeks. The study will gather real-world evidence to support the ongoing evaluation of this treatment in clinical practice.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older diagnosed with nAMD who are prescribed Beovu according to local guidelines.
Not a fit: Patients with contraindications to brolucizumab or those participating in other investigational drug trials may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the safety and effectiveness of Beovu, potentially improving treatment strategies for patients with nAMD.
How similar studies have performed: Other studies on post-marketing surveillance of similar treatments have shown success in providing important safety and efficacy data, making this approach well-established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients aged ≥18 years with nAMD that are prescribed with Brolucizumab as per approved local product information 2. Patients who consent to participate in the study after the purpose and nature of the study have clearly explained to them (written informed consent) Exclusion Criteria: 1. Contraindications as per local prescribing information 1) Hypersensitivity to the active substance or to any of the excipients. 2) Active or suspected ocular or periocular infection. 3) Active intraocular inflammation. 2. Patients participating in other investigational drug trial
Where this trial is running
Daegu, Dalseo Gu and 27 other locations
- Novartis Investigative Site — Daegu, Dalseo Gu, South Korea (Recruiting)
- Novartis Investigative Site — Goyang-si, Gyeonggi-do, South Korea (Recruiting)
- Novartis Investigative Site — Guri-si, Gyeonggi-do, South Korea (Recruiting)
- Novartis Investigative Site — Suwon, Gyeonggi-do, South Korea (Recruiting)
- Novartis Investigative Site — Iksan Si, Jeonlabuk Do, South Korea (Recruiting)
- Novartis Investigative Site — Daejeon, Korea, South Korea (Recruiting)
- Novartis Investigative Site — Busan, South Korea (Recruiting)
- Novartis Investigative Site — Busan, South Korea (Recruiting)
- Novartis Investigative Site — Busan, South Korea (Recruiting)
- Novartis Investigative Site — Daegu, South Korea (Recruiting)
- Novartis Investigative Site — Daegu, South Korea (Recruiting)
- Novartis Investigative Site — Gwangju, South Korea (Recruiting)
- Novartis Investigative Site — Gwangju, South Korea (Recruiting)
- Novartis Investigative Site — Incheon, South Korea (Recruiting)
- Novartis Investigative Site — Jeju City, South Korea (Recruiting)
- Novartis Investigative Site — Pusan, South Korea (Recruiting)
- Novartis Investigative Site — Seoul, South Korea (Recruiting)
- Novartis Investigative Site — Seoul, South Korea (Recruiting)
- Novartis Investigative Site — Seoul, South Korea (Recruiting)
- Novartis Investigative Site — Seoul, South Korea (Recruiting)
- Novartis Investigative Site — Seoul, South Korea (Recruiting)
- Novartis Investigative Site — Seoul, South Korea (Recruiting)
- Novartis Investigative Site — Seoul, South Korea (Recruiting)
- Novartis Investigative Site — Seoul, South Korea (Recruiting)
- Novartis Investigative Site — Seoul, South Korea (Recruiting)
- Novartis Investigative Site — Seoul, South Korea (Recruiting)
- Novartis Investigative Site — Seoul, South Korea (Recruiting)
- Novartis Investigative Site — Taegu, South Korea (Recruiting)
Study contacts
- Study coordinator: Novartis Pharmaceuticals
- Email: novartis.email@novartis.com
- Phone: +41613241111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.