An observational study in Neovascular Age-related Macular Degeneration (nAMD), sponsored by Novartis Pharmaceuticals. Terminated at 11 sites in Portugal. Open to participants aged 40 Years to 110 Years. Per ClinicalTrials.gov, last updated 2025-03-25.
Sponsored by Novartis Pharmaceuticals · Observational
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.
1,474 studies on the registry are indexed under Macular Degeneration; 206 are open to participants now.
This study's enrollment of 81 is below the median of 106 across 421 observational studies indexed under Macular Degeneration.
Browse Macular Degeneration studies →Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.
Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
This study will include an estimated number of 120 naïve patients and 180 switch patients with a diagnosis of nAMD being treated with brolucizumab in private clinics in Portugal during the recruitment period
Exclusion Criteria:
Naïve (Patients being the first time treated) and pre-treated patients
Drug: Brolucizumab
There is no treatment allocation. Patients administered Brolucizumab by prescription that have started before inclusion of the patient into the study will be enrolled.
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
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
Plan to share: No
This study is terminated, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Novartis Pharmaceuticals