JETREA® Drug Utilisation Study (TULIP) TG-MV-017

• Research type

  Research Study

• Full title

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

• IRAS ID

  152611

• Contact name

  Priya Prakash

• Contact email

  priya.prakash@pah.nhs.uk

• Sponsor organisation

  ThromboGenics NV

• Research summary

  This study is a European, multicentre, observational study. The study includes two parts, a drug utilisation study (DUS) and the Patient Educational Material Evaluation Survey (PEMES). The main objective of the DUS is to document JETREA® utilisation patterns in real-life clinical practice. 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.
  
  JETREA® was granted marketing authorisation (MA) approval by the U.S. Food and Drug Administration (FDA) in 2012 for treatment of symptomatic vitreomacular adhesion (VMA). On 13 March 2013, the European Medicines Agency’s (EMA) granted a marketing authorisation valid in all 28 EU Member States for the use of JETREA® in adults for the treatment of vitreomacular traction (VMT), including when associated with a macular hole of diameter less than or equal to 400 microns.
  EMA requested that a drug utilisation study (DUS) be undertaken to document JETREA® utilisation patterns in real life clinical practice, and to assess the effectiveness of the risk minimisation measures (i.e. the educational material provided to all patients prior to the injection of JETREA®). Such a study will allow assessment of how JETREA® is being used in “real-world” settings.

  This proposed multicentre, observational study, will include approximately 600 patients being treated with JETREA® at approximately 60-80 sites throughout selected European Union (EU) Member States. As part of the DUS, and subject to a specific consent, a subset of patients will be further contacted between 7 and 15 days after injection of JETREA® to complete the Patient Educational Material Evaluation Survey (PEMES). Approximately 150 patients will complete the PEMES.

• REC name

  East of England - Cambridgeshire and Hertfordshire Research Ethics Committee

• REC reference

  14/EE/1068

• Date of REC Opinion

  22 Jul 2014

• REC opinion

  Favourable Opinion