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The study was terminated earlier since the obtained sample was not representative of the Portuguese population, and pointed to the high fragility in evaluating the data, making it difficult to carry out a statistical study and draw valid conclusions.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brolucizumab | Naïve (Patients being the first time treated) and pre-treated patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brolucizumab | Drug | There is no treatment allocation. Patients administered Brolucizumab by prescription that have started before inclusion of the patient into the study will be enrolled. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Fluid resolution after initiation of brolucizumab | Detailed Outcome Measure will be defined in the Statistical Analysis Plan | month 24 |
| Visual Actuity (VA) change from baseline | Detailed Outcome Measure will be defined in the Statistical Analysis Plan |
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Inclusion Criteria:
Exclusion Criteria:
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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
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Funchal | 00-024 | Portugal | |||
| Novartis Investigative Site |
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| Label | URL |
|---|---|
| Results for CRTH258APT02 from the Novartis Clinical Trials Website | View source |
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| Baseline, month 24 |
| Characterize Choroidal Neovascularization (CNV) morphology (BIRL) and activity | Detailed Outcome Measure will be defined in the Statistical Analysis Plan | month 24 |
| Number of injections and total number of visits | Detailed Outcome Measure will be defined in the Statistical Analysis Plan | month 24 |
| Describe the distribution of injection intervals | Detailed Outcome Measure will be defined in the Statistical Analysis Plan | month 24 |
| Number of Spectral Contrast Optical Coherence Tomography (SC-OCTs) done | Detailed Outcome Measure will be defined in the Statistical Analysis Plan | 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 | month 24 |
| Discontinuation rate | Detailed Outcome Measure will be defined in the Statistical Analysis Plan | month 24 |
| Assess the safety of brolucizumab | Detailed Outcome Measure will be defined in the Statistical Analysis Plan | month 24 |
| Leiria |
| 2410-187 |
| Portugal |
| Novartis Investigative Site | Lisbon | 1050-078 | Portugal |
| Novartis Investigative Site | Lisbon | 1200-473 | Portugal |
| Novartis Investigative Site | Lisbon | 1500-473 | Portugal |
| Novartis Investigative Site | Lisbon | 1600-209 | Portugal |
| Novartis Investigative Site | Lisbon | 1649-020 | Portugal |
| Novartis Investigative Site | Lisbon | 1990-196 | Portugal |
| Novartis Investigative Site | Porto | 4050-115 | Portugal |
| Novartis Investigative Site | Santa Maria da Feira | 4520 211 | Portugal |
| Novartis Investigative Site | Tomar | 2300-625 | Portugal |
| ID | Term |
|---|---|
| C000622091 | brolucizumab |
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