INJECT: Investigation of JETREA® in patients with confirmed vitreo-macular traction

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Effectiveness study (incl. comparative)

  Other
• If ‘other’, further details on the scope of the study:
  Quality of Life
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medical condition to be studied:
  Vitreomacular interface abnormal

Population studied

• Short description of the study population:
  Patients exposed to ocriplasmin (JETREA®) across different countries according to each country's approved indications.
• Age groups:
  • 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)
• Special population of interest:
  Other
• Special population of interest, other:
  Patients with vitreomacular interface abnormality
• Estimated number of subjects:
  3000

Study design details

• Main study objective:
  The purpose of this study is to evaluate safety, clinical effectiveness, and health-related quality of life outcomes in a real world setting among a large population of patients exposed to ocriplasmin (JETREA®) across different countries according to each country's approved indications.
• Outcomes:
  Best-corrected visual acuity, pharmacological vitreo-macular traction resolution, pharmacological closure of macular hole, occurrence of vitrectomy, responses to NI VFQ-25 health-related quality of life questionnaire
• Data analysis plan:
  Underlying baseline demographic and clinical characteristics of patients enrolled in the study will be summarised in tabular format. For continuous variables, descriptive statistics will include the number of non‐missing observations N, mean and standard deviation mean, (SD), median and interquartile range median, (Q1, Q3), minimum and maximum values min, max, and number of missing observations missing, N. For categorical variables, descriptive statistics will include the frequency and percentage (n,%) of non‐missing values in each category.