Neovascular Age-related Macular Degeneration (nAMD)
Conditions
Keywords
Beovu, Brolucizumab, nAMD, non-interventional trial, fluid resolution
Brief summary
This study is a prospective, observational, non-interventional, multicenter, open-label, single arm study in patients being treated for nAMD with brolucizumab in Portugal.
Detailed description
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.
Interventions
DRUGBrolucizumab
There is no treatment allocation. Patients administered Brolucizumab by prescription that have started before inclusion of the patient into the study will be enrolled.
Sponsors
Novartis Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to 110 Years
Healthy volunteers
No
Inclusion criteria
1. Diagnosis of nAMD 2. Male and Female patients with ≥40 years of age at index 3. Receipt of at least one injection of brolucizumab during the recruitment period 4. Signed written informed consent
Exclusion criteria
1. Patients treated for RVO, DME, mCNV, and have diagnoses of diabetes-related macular degeneration within 6 months prior to the index date 2. Receipt of any anti-VEGF treatment other than brolucizumab in the study eye at index date 3. Central subfield of the study eye affected by fibrosis or geographic atrophy or total area of fibrosis \>50% of the total lesion in the study eye at Screening 4. Any active intraocular or periocular infection or active intraocular inflammation in either eye at index date 5. Patients who have been on anti-VEGF treatment for longer than 3 years (before index date) 6. Patients that have any contraindication and are not eligible for treatment with brolucizumab as according to the SmPC 7. Any medical or psychological condition in the treating physician's opinion which may prevent the patient from the 24 months study participation 8. Patients participating in parallel in an interventional clinical trial 9. Patients participating in parallel in any other NIS generating primary data for an anti-VEGF drug 10. Retinal pigment epithelial rip/tear in the study eye at Screening or Baseline or current vitreous hemorrhage or history of vitreous hemorrhage in the study eye within 4 weeks prior to Baseline 11. Subretinal blood affecting the foveal center point and/or \>50% of the lesion of the study eye at Screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients that are absent of subretinal fluid (SRF) and intra-retinal fluid (IRF) in the study eye | month 12 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Actuity (VA) change from baseline | Baseline, month 24 | Detailed Outcome Measure will be defined in the Statistical Analysis Plan |
| Characterize Choroidal Neovascularization (CNV) morphology (BIRL) and activity | month 24 | Detailed Outcome Measure will be defined in the Statistical Analysis Plan |
| Number of injections and total number of visits | month 24 | Detailed Outcome Measure will be defined in the Statistical Analysis Plan |
| Describe the distribution of injection intervals | month 24 | Detailed Outcome Measure will be defined in the Statistical Analysis Plan |
| Fluid resolution after initiation of brolucizumab | month 24 | Detailed Outcome Measure will be defined in the Statistical Analysis Plan |
| Characterize the patients switching to another antivascular endothelial growth factor (anti-VEGF) | month 24 | Detailed Outcome Measure will be defined in the Statistical Analysis Plan |
| Discontinuation rate | month 24 | Detailed Outcome Measure will be defined in the Statistical Analysis Plan |
| Assess the safety of brolucizumab | month 24 | Detailed Outcome Measure will be defined in the Statistical Analysis Plan |
| Number of Spectral Contrast Optical Coherence Tomography (SC-OCTs) done | month 24 | Detailed Outcome Measure will be defined in the Statistical Analysis Plan |
Countries
Portugal
Outcome results
None listed