Regulatory Post-Marketing Surveillance Study for Brolucizumab

Neovascular Age-related Macular Degeneration Clinical Trial

Official title:

Regulatory Post-Marketing Surveillance (rPMS) Study for Brolucizumab(Beovu ® Injection, Beovu ®Prefilled Syringe)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04985487
• Other study ID #: CRTH258AKR01
• Status: Recruiting
• Start date: August 18, 2021
• Est. completion date: June 14, 2026

Study information

• Verified date: June 2023
• Source: Novartis
• Contact: Novartis Pharmaceuticals
• Phone: +41613241111
• Email: novartis.email[@]novartis.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study is an open-label, multicenter, single-arm, observational post-marketing surveillance.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: June 14, 2026
• Est. primary completion date: June 14, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Macular Degeneration
• Neovascular Age-related Macular Degeneration

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Novartis Investigative Site	Busan
Korea, Republic of	Novartis Investigative Site	Busan
Korea, Republic of	Novartis Investigative Site	Busan
Korea, Republic of	Novartis Investigative Site	Daegu
Korea, Republic of	Novartis Investigative Site	Daegu
Korea, Republic of	Novartis Investigative Site	Daegu	Dalseo Gu
Korea, Republic of	Novartis Investigative Site	Daejeon	Korea
Korea, Republic of	Novartis Investigative Site	Goyang si	Gyeonggi Do
Korea, Republic of	Novartis Investigative Site	Guri-si	Gyeonggi-do
Korea, Republic of	Novartis Investigative Site	Gwangju
Korea, Republic of	Novartis Investigative Site	Gwangju
Korea, Republic of	Novartis Investigative Site	Iksan Si	Jeonlabuk Do
Korea, Republic of	Novartis Investigative Site	Incheon
Korea, Republic of	Novartis Investigative Site	Jeju
Korea, Republic of	Novartis Investigative Site	Pusan
Korea, Republic of	Novartis Investigative Site	Seoul
Korea, Republic of	Novartis Investigative Site	Seoul
Korea, Republic of	Novartis Investigative Site	Seoul
Korea, Republic of	Novartis Investigative Site	Seoul
Korea, Republic of	Novartis Investigative Site	Seoul
Korea, Republic of	Novartis Investigative Site	Seoul
Korea, Republic of	Novartis Investigative Site	Seoul
Korea, Republic of	Novartis Investigative Site	Seoul
Korea, Republic of	Novartis Investigative Site	Seoul
Korea, Republic of	Novartis Investigative Site	Seoul
Korea, Republic of	Novartis Investigative Site	Seoul
Korea, Republic of	Novartis Investigative Site	Suwon-si	Gyeonggi-do
Korea, Republic of	Novartis Investigative Site	Taegu

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events at 12 weeks	Incidence of adverse events and serious adverse events	12 weeks
Secondary	Incidence of adverse events at 24 weeks and optionally at 36 weeks	Incidence of adverse events and serious adverse events	Up to 36 weeks
Secondary	Proportion of patients gaining or losing more than 15 letters on the ETDRS chart	The ETDRS chart has been introduced as a standardized visual acuity (VA) testing chart. It uses 14 lines of 5 Sloan letter optotypes in each line in logarithmic progression. The space between lines and letters is proportionally equal keeping the effect of contour interaction constant. The threshold VA corresponds to the line in which 3 out of 5 optotypes were correctly identified. Alternatively, a by-letter scoring system (-0.02 logMAR credited for each letter correctly read) can be used. The testing distance can be varied; the corresponding visual acuity can be read easily from the chart. The chart is mounted on a box that is backlit by fluorescent tubes. For repeated measurements, the chart itself can be exchanged, providing different letters for different eyes.	Week 12, week 24, optionally week 36
Secondary	Mean change of Central Subfield Thickness (CST) from baseline	CST is measured as one parameter by Optical coherence tomography.	Baseline, week 12, week 24, optionally week 36
Secondary	Mean change of Best Corrected Visual Acuity (BCVA) from baseline	BCVA is the best possible vision that an eye can achieve with the use of glasses or contact lenses. It is measured by ETDRS chart or equivalent with the use of glasses or contact lenses	Baseline, week 12, week 24, optionally week 36
Secondary	Mean Best Corrected Visual Acuity (BCVA)	BCVA is the best possible vision that an eye can achieve with the use of glasses or contact lenses. It is measured by ETDRS chart or equivalent with the use of glasses or contact lenses	Baseline, week 12, week 24, optionally week 36
Secondary	Mean Central Subfield Thickness (CST)	CST is measured as one parameter by Optical coherence tomography.	Baseline, Week 12, week 24, optionally week 36
Secondary	Number of injections	Number of Brolucizumab injections to be collected	Up to 36 weeks
Secondary	Percentage of patients completing the loading phase	Loading phase: = 3 injection during first 4 months	4 months
Secondary	Percentage of patients who maintained with 12 weeks interval	Percentage(%) of patients who maintained with 12 weeks interval	Up to 36 weeks
Secondary	Proportion of patients with retinal fluid	Proportion of patients with Intraretinal fluid (IRF), subretinal fluid (SRF) or sub-retinal pigment epithelium (sub-RPE) fluid defined as presence/absence	Week 12, week 24, optionally week 36
Secondary	Prior anti-VEGF treatment history - number of prior injections	Number of injections of prior anti- vascular endothelial growth factor (VEGF) treatment	Baseline
Secondary	Prior anti-VEGF treatment history - agent of prior injections	Agent of prior anti - vascular endothelial growth factor (VEGF) injections	Baseline
Secondary	Predictive factors of treatment outcomes (persistent disease activity)	Predictive factors of patients identified with persistent disease activity. Persistent disease activity is defined as presence of fluid and CST of at least 200µm	Week 24
Secondary	Treatment naïve/non-naïve	Number of participants that are treatment naïve / non-naïve to be collected	Baseline
Secondary	Treatment interval	Number of participants by treatment interval to be collected	Up to week 36
Secondary	Concomitant treatments	Number of participants with concomitant treatments to be collected	Baseline
Secondary	Number of participants with post injection empirical treatment	Post injection emperical treatment means any medication or therapy (usually topical medication such as topical antibiotics, topical steroid..etc.) routinely prescribed on the same day of injection in order to prevent post injection complications. It is differentiated from concomitant medication.	Week 12, week 24, optionally week 36