An open label, registry study of the safety of ILUVIEN® 190 micrograms intravitreal implant in applicator (IRISS)

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Safety study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Non-randomized, open label, uncontrolled, multi-centre, safety study

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (S01BA15) fluocinolone acetonide

  fluocinolone acetonide
• Medical condition to be studied:
  Macular oedema

Population studied

• Short description of the study population:
  Any patient treated with ILUVIEN may be included in the study. ; Patients/Guardians who are unable to understand and sign the Informed Consent Form will be excluded from the study. ; ; Retrospective Enrolment Criteria:; Patients treated with ILUVIEN prior to study initiation may be included provided they satisfy the inclusion and exclusion criteria, where applicable, as well as, the following requirements:; 1. The site is allowed to enrol a patient who was treated with ILUVIEN no more than 36 months prior to bringing the patient in for their first study visit.; 2. The eligible patient must meet the data requirements as specified in the protocol, i.e., baseline data collected within 7 days prior to treatment with ILUVIEN and additional data subsequently collected approximately every 6 months thereafter until enrolment into the study.; 3. The eligible patient must be enrolled at least one year prior to the planned end of the study.
• 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)
• Estimated number of subjects:
  550

Study design details

• Main study objective:
  This study will assess the safety in patients treated with ILUVIEN. The specific objectives include the study of known safety risks, potential safety risks not observed in clinical trials, unknown safety risks, significant retinal ischaemia, removal of the implant, long-term safety data and repeat use and evaluation of safety in patients who have received ILUVIEN in both eyes.
• Data analysis plan:
  A sample size of 550 patients will provide approximately 80% probability of detecting one or more reports of any adverse event with a true underlying 5-year incidence of 0.3% assuming a 0.050 2-sided significance level. Data from all patients receiving an ILUVIEN implant will be included in the analyses of safety. Safety in specific subgroups, e.g. pregnant or lactating women and paediatric patients, will be evaluated. Formal study reports of analyses of study data will be performed at 3 years and 5 years. Analyses will also be conducted using preliminary data on an "as-needed" basis for marketing purposes and for Periodic Safety Update Reports. Safety analyses will be conducted to enumerate the number of patients with ocular and systemic adverse events, significant intraocular pressure related and cataract-related events, receiving retreatment, and undergoing implant explantation. Changes from baseline intraocular pressure and best corrected visual acuity will be summarized.