Post-Authorization Safety Study of OZURDEX® (Dexamethasone Intravitreal Implant): A Prospective Observational Study to Evaluate Long-Term Safety in Real-World Clinical Practice (CONSTANCE)

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
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Post-Authorization Safety Study, Prospective, observational study

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  100000098436

  dexamethasone
• Additional medical condition(s):
  Macular Oedema secondary to Central Retinal Vein Occlusion (CRVO) or Branch Retinal Vein Occlusion (BRVO) and inflammation of the posterior segment of the eye presenting as non-infectious uveitis (non-infectious posterior segment uveitis)

Population studied

• Short description of the study population:
  Patients who are treated with OZURDEX for macular oedema following Branch retinal vein occlusion (BRVO) or Central retinal vein occlusion (CRVO), or non-infectious posterior segment uveitis, under conditions of routine medical practice in accordance with the SmPC.; ; Inclusion Criteria:; 1. Age ≥ 18 years; 2. Physician diagnosis of macular oedema following either Branch Retinal Vein Occlusion (BRVO) or Central Retinal Vein Occlusion (CRVO) or non-infectious posterior segment uveitis.; 3. Treatment with OZURDEX (either initial or repeat); 4. Patients treated with OZURDEX in a completed clinical trial were eligible; 5. Patient or legal representative provides informed consent according to local regulations
• 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:
  Macular oedema patients
• Estimated number of subjects:
  650

Study design details

• Main study objective:
  To evaluate the long-term safety of OZURDEX®, including theidentified and potential risks as listed in the risk management plan, in patients withmacular oedema following RVO or non-infectious posterior segment uveitis who aretreated with OZURDEX® under conditions of routine medical practice.
• Outcomes:
  To evaluate the long-term safety of OZURDEX®, including the identified and potential risks as listed in the risk management plan, in patients with macular oedema following RVO or non-infectious posterior segment uveitis who are treated with OZURDEX® under conditions of routine medical practice.
• Data analysis plan:
  All SAEs and ADRs of special interest will be recorded and coded using MedDRA terms and presented by SOC, HLT, and PT. The demographic and clinical profile of the study population will be described using baseline data. All analyses will be stratified by indication and by new initiators of OZURDEX versus previously treated with OZURDEX. Frequency of SAEs and ADRs of special interest will be calculated as the number of patients who have a specific event starting during the study period, divided by the number of patients enrolled, multiplied by 100. Incidence rates of SAEs and ADRs of special interest will be estimated by dividing the number of incident cases by the person-time at risk and as annualized rates. Time at risk will be defined as the time between dates of first injection of OZURDEX to end of follow-up (completion of follow-up / study discontinuation). Case narratives will be provided for each SAE and ADRs of special interest.

Documents

Study results

Allergan_Ozurdex_PASS_Abstract_Redacted