Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2025-12-25 @ 9:57 PM
Study NCT ID:
NCT05657158
Status:
COMPLETED
Last Update Posted:
2022-12-20
First Post:
2022-11-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Analysis of Imaging Features From Patients Treated With Brolucizumab in the Post-marketing Setting With Reports of Retinal Vasculitis and/or Retinal Vascular Occlusion
Sponsor:
Novartis Pharmaceuticals
Organization:
Study Overview
Official Title:
Retrospective Analysis of Imaging and Clinical Features From Patients Treated With Brolucizumab in Post-marketing Setting With Reports of Intraocular Inflammation and/or Retinal Vascular Occlusion
Status:
COMPLETED
Status Verified Date:
2022-12
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:
None
Brief Summary:
This non-interventional descriptive study was undertaken to better understand the most common imaging features associated with inflammation arising in the post-marketing setting when brolucizumab was prescribed in routine clinical practice.
Detailed Description:
The purpose of this retrospective study analysis was to better characterize the risk of inflammatory events arising from use of brolucizumab in routine clinical practice through analysis of independently reviewed ocular imaging data obtained from cases with reports of intraocular inflammation (IOI), retinal vasculitis (RV) and/or Retinal vascular occlusion (RO) and to provide a description of these features.
Whenever an AE report pertaining to RV and/or RO was reported to Novartis Patient Safety, a follow-up check list (targeted follow-up checklists \[TFUs\]) was sent by Novartis to the reporter. The reporter was encouraged to share all available images obtained as part of clinical practice, irrespective of the timing or event (i.e. images before, during, and after event could be provided). The focus and main efforts of this data collection was on adverse events of RV and/or RO; for other IOI only events, the images were not actively requested in the case documentation process, however in some cases these were spontaneously reported by the reporter.
All images obtained from Feb 2020 up to 31 Jan 2021 were reviewed in a standardized manner by an external reading center. Dedicated grading lists were developed for each of the image modalities: Fluorescein Angiography (FA), Fundus Photography (FP), Indocyanine Green Angiography (ICGA), Optical Coherence Tomography (OCT), and OCT Angiography (OCT-A).
Whenever an AE report pertaining to RV and/or RO was reported to Novartis Patient Safety, a follow-up check list (targeted follow-up checklists \[TFUs\]) was sent by Novartis to the reporter. The reporter was encouraged to share all available images obtained as part of clinical practice, irrespective of the timing or event (i.e. images before, during, and after event could be provided). The focus and main efforts of this data collection was on adverse events of RV and/or RO; for other IOI only events, the images were not actively requested in the case documentation process, however in some cases these were spontaneously reported by the reporter.
All images obtained from Feb 2020 up to 31 Jan 2021 were reviewed in a standardized manner by an external reading center. Dedicated grading lists were developed for each of the image modalities: Fluorescein Angiography (FA), Fundus Photography (FP), Indocyanine Green Angiography (ICGA), Optical Coherence Tomography (OCT), and OCT Angiography (OCT-A).
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: