June 2017
Volume 58, Issue 8
Open Access
ARVO Annual Meeting Abstract  |   June 2017
Initial efficacy, anatomic and safety outcomes after fluocinolone acetonide 0.2 µg/day implant in patients with DME: The PALADIN real-world observational study
Author Affiliations & Notes
  • Sam Mansour
    Virginia Retina Center, Warrenton, Virginia, United States
    The George Washington University, Washington, District of Columbia, United States
  • Footnotes
    Commercial Relationships   Sam Mansour, Alcon (C), Alimera Sciences (C), Allergan Inc. (C), Diopsys Corporation (C), Genentech (C), Iridex Corporation (C)
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science June 2017, Vol.58, 926. doi:
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      Sam Mansour; Initial efficacy, anatomic and safety outcomes after fluocinolone acetonide 0.2 µg/day implant in patients with DME: The PALADIN real-world observational study. Invest. Ophthalmol. Vis. Sci. 2017;58(8):926.

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      © ARVO (1962-2015); The Authors (2016-present)

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Purpose : To determine real-world visual and anatomic outcomes following treatment with fluocinolone acetonide 0.2 µg/day (FAc; ILUVIEN®) in patients with diabetic macular edema (DME), previously treated with corticosteroids without developing elevated IOP, and to evaluate outcomes by baseline vision and additional post-implant treatment.

Methods : Prospective non-randomized, open-label Phase 4 study, aiming to enroll ~300 patients at 60 US study centers. Patients were eligible for FAc treatment based on the Prescribing Information. Baseline characteristics, including DME duration, best corrected visual acuity (BCVA), central subfield thickness (CST), intraocular pressure (IOP) and lens status were evaluated in 112 patients. Changes from baseline BCVA (n=53) and CST (n=49) after 6 months were assessed and analyzed by baseline vision; additional therapies following FAc implant were reported.

Results : At Month 6, significant improvements compared with baseline were observed in overall mean BCVA and CST (+3.0 ETDRS letters, P=0.05; -38.8 microns, P=0.02) in FAc implant-treated patients. Changes from baseline in mean BCVA and CST were greatest in patients with baseline vision worse than 20/100 (Table 1). Among the 53 eyes assessed at Month 6, 62% received no additional DME treatments. For those receiving adjunctive therapy, anti-VEGF was administered in 18 eyes (34%) with an average of 2.6 injections over 6 months. During the 6-month period, the mean number of additional DME injections was similar in patients with better vision and those with 20/100 or worse. Mean IOP was not changed at 6 months compared with baseline (15 mmHg and 14 mmHg, respectively). IOP increased in 9 eyes (6.9%) but none required IOP-lowering surgery. Cataracts developed in 8 eyes (6.1%); only 1 required surgery (0.8%).

Conclusions : Initial 6-month outcomes demonstrated anatomic and visual improvements from baseline following FAc implant. Patients with the worst vision at baseline achieved the most improvement in visual and anatomic outcomes. Data up to 6 months suggests comparable decline in the number of additional DME treatments following FAc implant whether vision is worse than 20/100 or better than 20/40. Further analyses will describe the magnitude of treatment burden prior to and following FAc therapy; however, longer-term data is required.

This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.



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