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Victor H Gonzalez; Optimization of diabetic macular edema (DME) therapy following 0.2 µg/day fluocinolone acetonide (FAc) implant administration. Invest. Ophthalmol. Vis. Sci. 2018;59(9):4848. doi: https://doi.org/.
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PALADIN and USER are real-world, multicenter studies assessing the safety and efficacy of the 0.2 µg/day FAc implant in patients with DME. Data from these two independent studies were used to assess the potential for the FAc implant to optimize DME treatment.
Patients enrolled in both PALADIN and USER had DME and were treated with the 0.2 µg/day FAc implant based on the US indication. Treatment frequency was calculated as the reciprocal of the mean number of treatments per month. Patient subgroups were analyzed to determine the effect of baseline visual acuity (VA) on treatment frequency pre- and post-0.2 µg/day FAc implant administration.
Significant differences in DME treatment frequency were observed pre- and post-FAc implant administration in both PALADIN (1 treatment every 3.72 months vs 1 treatment every 7.87 months; p<0.001) and USER (1 treatment every 2.9 months vs 1 treatment every 14.3 months; p<0.001). In both studies, in eyes with better VA at baseline, VA was maintained post-FAc using significantly fewer DME treatments compared with pre-FAc treatment. In both studies, patients with worse vision achieved significantly improved VA with fewer injections following treatment with the FAc implant. In the USER study, patients received 1 treatment every 2–3 months, regardless of baseline VA pre-FAc. Following FAc treatment, patients with worse baseline VA received more frequent DME treatments compared with those with better baseline VA. This result was confirmed in the PALADIN study, in which patients received 1 treatment every 3–4 months prior to treatment with FAc; however, following 0.2 µg/day FAc, patients with baseline VA ≥20/40 received 1 treatment every 10.20 months, while patients with baseline VA <20/40 received 1 treatment every 6.90 months.
Prior to treatment with 0.2 µg/day FAc, patients in both studies received, on average, 1 treatment every 2–4 months, regardless of VA. Following treatment with FAc, patients received DME treatment according to their baseline VA; patients with better baseline VA received less frequent DME treatments following FAc administration, whilst patients with worse baseline VA received more frequent DME treatments allowing for the customization of therapy.
This is an abstract that was submitted for the 2018 ARVO Annual Meeting, held in Honolulu, Hawaii, April 29 - May 3, 2018.
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