Two-year interim safety results of the 0.2 µg/day fluocinolone acetonide intravitreal implant for the treatment of diabetic macular oedema: The observational PALADIN study
British Journal of Ophthalmology May 31, 2020
Mansour SE, Kiernan DF, Roth DB, et al. - Given that the 0.2 µg/day fluocinolone acetonide (FAc) implant delivers continuous, low-dose, intravitreal corticosteroid for the treatment of diabetic macular oedema (DMO), researchers conducted this ongoing, 3-year, observational clinical trial to provide long-term, ‘real-world’ safety outcomes for the FAc implant in DMO. In this 24-month interim analysis of a prospective, observational study, they examined patients with DMO receiving the commercially available intravitreal 0.2 µg/day FAc implant. Data were obtained from 95 previously steroid-challenged patients (115 study eyes) for up to 36 months pre-FAc and 24 months post-FAc implant. During the 24 months post-FAc implant, few IOP-related procedures were reported. After treatment, positive efficacy results were noted, with vision stabilisation and inflammation reduction, as demonstrated by CST. The FAc implant has a favourable benefit–risk profile in DMO management, particularly when administered after a steroid challenge beforehand.
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