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

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/48564
• EU PAS number:
  EUPAS41014
• Study ID:
  48564
• Official title and acronym:
  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
• DARWIN EU® study:
  No
• Study countries:
  Switzerland
• Study description:
  Post-marketing eye cases of RV and/or RO reported to Novartis Patient Safety from which ocular images were requested and provided to Novartis until 31-Jan-2021, from all countries where brolucizumab was approved and used per routine clinical practice, were considered for this study. Of note, the few IOI cases, for which images were provided, were also included in the analysis.
• Study status:
  Finalised

Research institutions and networks

Institutions

Novartis Pharmaceuticals

Study timelines

Date when funding contract was signed

Planned: 04/08/2020

Actual: 04/08/2020

Study start date

Planned: 17/05/2021

Actual: 24/08/2021

Data analysis start date

Planned: 17/05/2021

Actual: 04/01/2022

Date of final study report

Planned: 31/01/2022

Actual: 22/02/2022

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Novartis AG

Study protocol

Initial protocol

CRTH258A2404_Global NIS Protocol Amendment_Redacted

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable

Other study registration identification numbers and links

CRTH258A2404