A retrospective, 12-month, multicenter study to evaluate real-world brolucizumab effectiveness and safety in Japanese patients with neovascular age-related macular degeneration (nAMD)

JRCT ID: jRCT1050210159

Registered date:22/01/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: neovascular Age-related Macular Degeneration
• Date of first enrollment: 26/04/2022
• Target sample size: 500
• Study type: Observational

Outcome(s)

Primary Outcome

Percentage(%) of patients that are absent of SRF and IRF at Month 12.
The endpoint formulated in estimand terms is :
-Population : real-world nAMD patients
-Treatment : brolucizumab as received in routine care
-Variable(Endpoint / Outcome) : composite binary: absence of IRF and the absence of SRF.
-Summary measure for the variable : percentage of treated patients who reach the endpoint at 12 months
-Intercurrent events treatment discontinuation for any reason (including switching to another anti-VEGF)
-Strategy how to deal with intercurrent events : while-on-treatment strategy.
Patients who have discontinued brolucizumab before Month 12 will be counted as not having achieved the endpoint of fluid resolution (absence of SRF and IRF), unless they reached it at the last visit while still on brolucizumab treatment before the discontinuation.

Key inclusion & exclusion criteria

• Age minimum: >= 50age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1.Diagnosis of nAMD
2.Patients with >= 50 years of age at index
3.Receipt of first injection of brolucizumab during the index period
4.Signed or Verbal informed consent

Exclude criteria

1. Patients treated for RVO, DME, mCNV, and have diagnoses of diabetes-related macular degeneration within 6 months prior to the index date
2. Any active intraocular or periocular infection or active intraocular inflammation in the study eye at index date
3.Patients who have any contraindication and are not eligible for treatment with brolucizumab as according to the label
4. Patients who were treated with more than 3 types of anti-VEGF before index date (5th line brolucizumab patients or more)
5. Patients participating in parallel in an interventional clinical trial
Note: if a patient experiences an adverse event, they may still be recruited in another study following this adverse event if they fulfill their inclusion criteria. Their data will still be collected as planned by the current protocol
6. Patients participating in Post-Marketing surveillance with brolucizumab

Related Information

• Primary Sponsor: Takuma Okada