Use of Intravitreal JETREA in Clinical Practice: A European Prospective Drug Utilisation Study (TG-MV-017) (TULIP)

Study identification

• EU PAS number:
  EUPAS4796
• Study ID:
  27262
• Official title and acronym:
  Use of Intravitreal JETREA in Clinical Practice: A European Prospective Drug Utilisation Study (TG-MV-017) (TULIP)
• DARWIN EU® study:
  No
• Study countries:
  Germany

  Italy

  Spain

  United Kingdom
• Study description:
  This study is a European, multicentre, observational study. The study includes two parts, a drug utilisation study (DUS) and a Patient Educational Material Evaluation Survey (PEMES). The main objective of the DUS is to document JETREA® utilisation patterns in real-life clinical practice (including off label use and medication errors). The objective of the PEMES is to assess the effectiveness of the risk minimisation measures (i.e. the educational material provided to patients prior to the injection of JETREA®). The PEMES will be carried out in a subset of patients participating in the DUS.
• Study status:
  Finalised

Research institutions and networks

Institutions

ThromboGenics NV

Multiple centres: 37 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned:07/11/2012

Actual:07/11/2012

Study start date

Planned:30/05/2014

Actual:14/10/2014

Data analysis start date

Actual:31/10/2017

Date of final study report

Planned:14/10/2018

Actual:22/02/2018

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Alcon, A Novartis Division

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)