Status:
TERMINATED
Observational Study to Evaluate Fluid Resolution and Effectiveness of Brolucizumab for nAMD in Portugal
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Neovascular Age-related Macular Degeneration (nAMD)
Eligibility:
All Genders
40-110 years
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 ch...
Eligibility Criteria
Inclusion
- Diagnosis of nAMD
- Male and Female patients with ≥40 years of age at index
- Receipt of at least one injection of brolucizumab during the recruitment period
- Signed written informed consent
Exclusion
- Patients treated for RVO, DME, 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 at index date
- 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
- Any active intraocular or periocular infection or active intraocular inflammation in either eye at index date
- Patients who have been on anti-VEGF treatment for longer than 3 years (before index date)
- Patients that have any contraindication and are not eligible for treatment with brolucizumab as according to the SmPC
- Any medical or psychological condition in the treating physician's opinion which may prevent the patient from the 24 months study participation
- Patients participating in parallel in an interventional clinical trial
- Patients participating in parallel in any other NIS generating primary data for an anti-VEGF drug
- 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
- Subretinal blood affecting the foveal center point and/or \>50% of the lesion of the study eye at Screening
Key Trial Info
Start Date :
May 10 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 16 2024
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT04764656
Start Date
May 10 2021
End Date
February 16 2024
Last Update
March 25 2025
Active Locations (11)
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1
Novartis Investigative Site
Funchal, Portugal, 00-024
2
Novartis Investigative Site
Leiria, Portugal, 2410-187
3
Novartis Investigative Site
Lisbon, Portugal, 1050-078
4
Novartis Investigative Site
Lisbon, Portugal, 1200-473