A Study to Evaluate Real-world Brolucizumab Effectiveness and Safety in Japanese Patients With Neovascular Age-related Macular Degeneration (nAMD)
Completed
Conditions studied: Neovascular Age-Related Macular Degeneration
In brief
A retrospective, observational, single-arm, non-randomized cohort study of ocular treatment in nAMD patients in Japan who had records of at least 12 months of follow-up after their first brolucizumab intravitreal injection. Patients who had records of at least 12 months of visits after the first brolucizumab injection (index date) were identified during the index period and were recruited during the data collection/recruitment period.
Key facts
- Study ID
- NCT06699914
- Run by
- Novartis Pharmaceuticals
- People needed
- 438
- Starts
- 2022-09-06
- Expected to finish
- 2023-12-01
- Last updated by the study team
- 2024-11-21
Who can join
Age: 50 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Diagnosis of nAMD.
- Patients 50 years of age or older at index.
- Received first injection of brolucizumab during the index period.
- Gave signed or verbal informed consent.
You may not qualify if…
- Patients treated for retinal vein occlusion (RVO), diabetic macular edema (DME), myopic choroidal neovascularization (mCNV), and who had diagnoses of diabetes-related macular degeneration within 6 Months prior to the index date.
- Any active intraocular or periocular infection or active intraocular inflammation in the study eye at index date.
- Patients who had any contraindication and were not eligible for treatment with brolucizumab according to the label.
- Patients who were treated with more than 3 types of anti-vascular endothelial growth factor (anti-VEGF) before the index date (5th line brolucizumab patients or more).
- Patients participating in parallel in an interventional clinical trial.
- Patients participating in post-marketing surveillance with brolucizumab.
Where it is running
- Novartis — East Hanover, New Jersey, United States
Full record on ClinicalTrials.gov
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