MULTICENTER PROSPECTIVE OBSERVATIONAL STUDY ON THE TREATMENT OF OPHTHALMIC INFLAMMATORY DISEASES NOT RESPONDING TO LOCAL STEROIDS WITH INTRAVITREAL TRIAMCINOLONE ACETONIDE

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)
• Data collection methods:
  Primary data collection

Study drug and medical condition

• Medicinal product name, other:
  TAIOFTAL
• Medical condition to be studied:
  Macular oedema

Population studied

• Short description of the study population:
  Patients affected by diabetic macular oedema due to inflammatory aetiology of the diseases treated 8% suspension of triamcinolone acetonide (Taioftal®).
• 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 diabetic macular oedema
• Estimated number of subjects:
  50

Study design details

• Main study objective:
  To evaluate the tolerability of intravitreal injections of an 8% suspension of triamcinolone acetonide (Taioftal®) on patients affected by diabetic macular oedema due to inflammatory aetiology of the diseases.
• Outcomes:
  Intraocular pressure measured by Goldmann applanationtonometry,• Cataract occurrence or worsening,• Vitreal reaction evaluated by slit lamp examination and/or OCTanalysis,• Ocular surface analysed by slit lamp,• Every other side effect to be reported in the CRF. macular thikness by OCT,visual acuity
• Data analysis plan:
  This is an observational non-comparative study, then no formal samplesize estimate is needed. Previous studies on the treatment of diabeticmacular edema enrolled between 30 and 70 patients, regardless if theywere observational non-comparative or comparative clinical trials. Forthis reason, 50 patients can be considered a sample size large enough toinvestigate the above mentioned endpoints. This is even more trueconsidering that most of the patients will suffer from diabetic macularedema at both eyes. Analyzing each single eye, the sample size will beautomatically increased.Comparisons with baseline measurements will be performed. The resultswill be then compared with similar findings published in the literature.