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

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Observational study

Population studied

• Short description of the study population:
  Patients with vitreomacular traction (VMT), on which ophthalmologists independently decided to administer Ocriplasmin (JETREA).
• Age groups:
  • Preterm newborn infants (0 – 27 days)
  • Term newborn infants (0 – 27 days)
  • Infants and toddlers (28 days – 23 months)
  • Children (2 to < 12 years)
  • Adolescents (12 to < 18 years)
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)
• Estimated number of subjects:
  300

Study design details

• Main study objective:
  The main objective of the DUS is to document JETREA® utilisation patterns in real-life clinical practice (including off label use and medication errors).
• Data analysis plan:
  All data collected, including patient demographics, medical, general ocular and ocular intervention history, current ocular status, JETREA® utilisation information and anticipated treatment plan for the patient will be analysed descriptively.