This study is a prospective, observational, non-interventional, multicenter, open-label, single arm study in patients being treated for nAMD with brolucizumab in Portugal.
Naïve and pre-treated patients will be included after decision to start treatment with brolucizumab and consent is given. The baseline visit will be used to assess eligibility and collect baseline characteristics information. The study eye will be defined as the first eye treated during the study; the other eye will be considered as fellow eye. If both eyes are treated at baseline, the eye with the worse visual acuity will be chosen as the study eye (if the visual acuity is measured equal, the treating ophthalmologist defines the study eye upon his discretion). The follow-up visits will take place at a frequency defined as per investigator's discretion. Patients that have not received an intravitreal anti-VEGF injection or visited an eye specialist for at least 6 months will be discontinued from the observation. Retrospective data will be collected for switch patients starting treatment with brolucizumab for up to six months before baseline. Patients, already being treated with brolucizumab may also be included. Here, retrospective data will be collected since the first brolucizumab injection.
Study Type
OBSERVATIONAL
Enrollment
81
There is no treatment allocation. Patients administered Brolucizumab by prescription that have started before inclusion of the patient into the study will be enrolled.
Novartis Investigative Site
Funchal, Portugal
Novartis Investigative Site
Leiria, Portugal
Novartis Investigative Site
Lisbon, Portugal
Percentage of patients that are absent of subretinal fluid (SRF) and intra-retinal fluid (IRF) in the study eye
This primary study objective will be addressed considering treatment naïve and pre-treated patient eyes included in the study, analyzed as two independent groups (naïve and switch).
Time frame: month 12
Fluid resolution after initiation of brolucizumab
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Time frame: month 24
Visual Actuity (VA) change from baseline
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Time frame: Baseline, month 24
Characterize Choroidal Neovascularization (CNV) morphology (BIRL) and activity
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Time frame: month 24
Number of injections and total number of visits
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Time frame: month 24
Describe the distribution of injection intervals
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Time frame: month 24
Number of Spectral Contrast Optical Coherence Tomography (SC-OCTs) done
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Time frame: month 24
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Novartis Investigative Site
Lisbon, Portugal
Novartis Investigative Site
Lisbon, Portugal
Novartis Investigative Site
Lisbon, Portugal
Novartis Investigative Site
Lisbon, Portugal
Novartis Investigative Site
Lisbon, Portugal
Novartis Investigative Site
Porto, Portugal
Novartis Investigative Site
Santa Maria da Feira, Portugal
...and 1 more locations
Characterize the patients switching to another antivascular endothelial growth factor (anti-VEGF)
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Time frame: month 24
Discontinuation rate
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Time frame: month 24
Assess the safety of brolucizumab
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Time frame: month 24