July 2019
Volume 60, Issue 9
Open Access
ARVO Annual Meeting Abstract  |   July 2019
Consistent Improvements in Retinal Thickness Amplitude Achieved with the 0.19 mg Fluocinolone Acetonide Implant in Patients with DME: Results from FAME, PALADIN and USER studies
Author Affiliations & Notes
  • Christopher D Riemann
    Cincinnati Eye Institute / University of Cincinnati, Cincinnati, Oklahoma, United States
  • Footnotes
    Commercial Relationships   Christopher Riemann, AGTC (F), Alcon (C), Alimera (C), Allergan (R), Arepio (F), Bausch & Lomb/Valeant (R), BMC/Eyetube (R), Clearside (F), CSTLII (R), Gore (C), Haag Streit (C), HumanOptics (R), Iamc2 (I), iVeena (I), Janssen/Johnson&Johnson (P), Kaleidoscope Engineering (C), Macor Industries (I), MedOne (P), Northmark Pharmacy (I), NotalVision (C), Orbit BioMedical (C), Reliance Industries (I), TrueVision (I), VEO-Ophthalmics (I), Vortex (I)
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science July 2019, Vol.60, 2633. doi:
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      Christopher D Riemann; Consistent Improvements in Retinal Thickness Amplitude Achieved with the 0.19 mg Fluocinolone Acetonide Implant in Patients with DME: Results from FAME, PALADIN and USER studies. Invest. Ophthalmol. Vis. Sci. 2019;60(9):2633.

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

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Abstract

Purpose : Real-world studies have shown the 0.19 mg fluocinolone acetonide (FAc; ILUVIEN) implant effectively reduces central subfield thickness (CST) in patients with DME. We investigate an alternate interpretation of edema control, the RTA calculation, which allows the characterization of CST stability and comparisons to be made across pivotal datasets (i.e. FAME, PALADIN and USER).

Methods : Three studies involving a total of 643 eyes with DME treated with the FAc implant were included in this analysis: 1) Prospective cohort of 324 eyes from the FAME trial with 3 years follow-up (phase III RCT); 2) 199 eyes from the PALADIN study with 526 days follow-up (phase IV study); and, 3) 120 eyes from the US retrospective chart review with over 403 days of follow-up, and included as a comparator. RTA, expressed in microns, was calculated as the maximum range of the retinal thickness fluctuation based on the difference between minimum and maximum CST for each eye receiving the FAc implant. RTA value across subgroups including lens status, baseline visual acuity and last DME treatment were assessed. Values are reported as means throughout.

Results : In the FAME study, RTA in the FAc implant treated patients was significantly reduced compared to sham treated patients (186.8 µm versus 239.7 µm respectively, p<0.001). In the PALADIN study, RTA decreased from 245.5 µm in the pre FAc period to 132.4 µm post-FAc (a difference of 113.1 µm; p<0.001). In the USER study, RTA decreased from 230.9 µm to 96.4 µm (pre- to post-FAc implant) (a difference of 134.5 µm; p<0.001). Subgroup analyses showed statistically significant improvements in pseudophakic eyes (p£0.002; all studies). In USER and PALADIN studies, RTA values post-FAc implant were significantly reduced regardless of last intervention prior to FAc. Across the real-world studies, the least fluctuation in retinal thickness as measured by RTA occurred in eyes with VA 20/40 or better at baseline; p<0.001).

Conclusions : Across all the datasets analyzed, RTA analysis showed consistent reductions in edema variability post FAc implant which validates the value of the RTA measure. Greatest control of edema was reported in subgroups with best VA at the time of FAc implantation. Continuous treatment with daily delivery of FAc provides expanded value to regulation of CST changes in DME eyes.

This abstract was presented at the 2019 ARVO Annual Meeting, held in Vancouver, Canada, April 28 - May 2, 2019.

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