Ignite Creation Date:
2024-05-06 @ 3:48 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04764656
Status:
COMPLETED
Last Update Posted:
2024-07-10
First Post:
2021-02-19
Brief Title:
Observational Study to Evaluate Fluid Resolution and Effectiveness of Brolucizumab for nAMD in Portugal
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
Observational Study to Evaluate Fluid Resolution and Effectiveness of Brolucizumab for Neovascular Age-related Macular Degeneration nAMD in Portugal
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BLUESKY-PT
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 investigators 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
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 investigators 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None