NCT06699914Completed
A Study to Evaluate Real-world Brolucizumab Effectiveness and Safety in Japanese Patients With Neovascular Age-related Macular Degeneration (nAMD)
A Retrospective, 12-month, Multicenter Study to Evaluate Real-world Brolucizumab Effectiveness and Safety in Japanese Patients With Neovascular Age-related Macular Degeneration (nAMD) - the PHEASANT Study - a Study Following the Master Protocol
Source: ClinicalTrials.gov · Last updated 21 Nov 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 438 (actual)
- First submitted
- 19 Nov 2024
- Start date
- 6 Sept 2022
- Primary completion date
- 1 Dec 2023
- Lead sponsor
- Novartis Pharmaceuticals
- Diseases
- Macular degeneration
- NCT number
- NCT06699914
What you commit to
- Study type: Observational
- Participants enrolled: 438
- From 6 Sept 2022 to the primary completion date, 1 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- 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).
Other illness
- Any active intraocular or periocular infection or active intraocular inflammation in the study eye at index date.
Other
- Patients participating in parallel in an interventional clinical trial.
- Patients participating in post-marketing surveillance with brolucizumab.
Who the study is looking for
- 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.
Age in the registry: 50 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Novartis Coordinator of this site? Confirm its status | East Hanover | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.