An argument rattles on through the ages: what’s the value of a clinical trial, if real-world results don’t match up? There are many reasons for the disparity – the two main ones being i) careful trial patient selection that doesn’t match the characteristics of real-world patients, and ii) closer supervision and dose adherence in the trial than in practice. But when it comes to long-acting implanted formulations of drugs, the second point is moot; patients should continue to receive therapeutic doses of the drug for the lifetime of the implant. And what if the population in the real world was very different to the clinical trial? It was against this background that the five-year, international, multicenter prospective open-label Iluvien Registry Safety Study (IRISS) (1) was performed in 593 eyes (from 563 patients with a [chronic] diagnosis of diabetic macular edema [DME], mean age 67.5 ± 10.7 years, 56.3 percent male) to answer the question: does the sustained-release fluocinolone acetonide 190 µg intravitreal implant work to treat DME in the real world – and for how long?
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