Status:
TERMINATED
Effectiveness of Brolucizumab in Pre-treated Patients With nAMD in the Real-world Setting
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Neovascular Age-related Macular Degeneration
Eligibility:
All Genders
18-100 years
Brief Summary
The study is a prospective and retrospective, observational, single-arm, non-randomized cohort study of ocular treatment with intravitreal injections of brolucizumab in nAMD patients. This study will ...
Detailed Description
Retrospective data will be collected for all patients starting treatment with brolucizumab for up to 12 months before baseline. Patients who received brolucizumab before the study start will be recru...
Eligibility Criteria
Inclusion
- Diagnosis of nAMD
- Patients with ≥18 years of age at index
- Receipt of at least one injection of brolucizumab (not necessarily the first one) during the index period
- Signed informed consent
Exclusion
- Patients treated for retinal vein occlusion (RVO), diabetic macular edema (DME), myopic choroidal neovascularization (mCNV), and have diagnoses of diabetes-related macular degeneration within 6 months prior to the index date
- Receipt of any anti-VEGF treatment other than brolucizumab in the study eye during the index period
- Receipt of brolucizumab in the study eye more than 6 months before the index period, i.e., brolucizumab treatment started more than 6 months before the start of the study
- Any active intraocular or periocular infection or active intraocular inflammation in the study eye at index date
- Patients who have any contraindication and are not eligible for treatment with brolucizumab as according to the label
- Patients who were treated with more than 2 types of anti-VEGF before index date (4th line brolucizumab patients or more)
- Any medical or psychological condition in the treating physician's opinion which may prevent the patient from the 12-month study participation
- Patients participating in parallel in an interventional clinical trial Note: if a patient experiences an adverse event (AE), they may still be recruited in another study following this AE if they fulfill their inclusion criteria. Their data will still be collected as planned by the current protocol
- Patients participating in parallel in any other NIS generating primary data for an anti-VEGF drug
Key Trial Info
Start Date :
April 13 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 13 2023
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT05266495
Start Date
April 13 2022
End Date
March 13 2023
Last Update
January 13 2025
Active Locations (1)
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1
Novartis Investigative Site
Abu Dhabi, United Arab Emirates, 112412