June 2023
Volume 64, Issue 8
Open Access
ARVO Annual Meeting Abstract  |   June 2023
Long-Term Control of Retinal Thickness Variability Improves Vision Following the 0.19mg Fluocinolone Acetonide in Patients with DME: The PALADIN Study
Author Affiliations & Notes
  • Veeral Sheth
    University Retina and Macula Associates PC, Chicago, Illinois, United States
    University of Illinois Chicago, Chicago, Illinois, United States
  • Jonathan Kasper
    Alimera Sciences Inc, Alpharetta, Georgia, United States
  • Brandon Coughlin
    Alimera Sciences Inc, Alpharetta, Georgia, United States
  • Antonio Cutino
    Alimera Sciences Inc, Alpharetta, Georgia, United States
  • Footnotes
    Commercial Relationships   Veeral Sheth Genentech, Code C (Consultant/Contractor), Alimera, Code C (Consultant/Contractor), Apellis, Code C (Consultant/Contractor), EyePoint, Code C (Consultant/Contractor), IvericBio, Code C (Consultant/Contractor), Regeneron, Code C (Consultant/Contractor); Jonathan Kasper Alimera Sciences, Inc., Code E (Employment); Brandon Coughlin Alimera Sciences, Inc., Code E (Employment); Antonio Cutino Alimera Sciences, Inc., Code E (Employment), Alimera Sciences, Inc., Code I (Personal Financial Interest)
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science June 2023, Vol.64, 2632. doi:
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      Veeral Sheth, Jonathan Kasper, Brandon Coughlin, Antonio Cutino; Long-Term Control of Retinal Thickness Variability Improves Vision Following the 0.19mg Fluocinolone Acetonide in Patients with DME: The PALADIN Study. Invest. Ophthalmol. Vis. Sci. 2023;64(8):2632.

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

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Abstract

Purpose : In the real world, current therapies fall short in their ability to reduce the recurrence of edema, and the subsequent retinal thickness variability (RTV) can lead to irreversible vision loss. The PALADIN phase IV, prospective study highlights the ability of the long-acting 0.19 mg FAc implant to reduce retinal thickness variability and improve vision for up to 36 months.

Methods : 151 eyes met the criteria for analyzing RTV: 1) area under the curve of central subfield thickness (AUC-CST) – ≥3 CST measurements pre- and post-FAc and 2) retinal thickness amplitude (RTA) and standard deviation (RTSD) – ≥3 CST measurements pre-FAc and ≥3 CST measurements 6 months post-FAc. Study assessments, such as CST and best-corrected VA (BCVA), were taken at baseline, day 7, month 2, month 3, and then quarterly for up to 36 months. Correlations were performed using last observed BCVA, and post-FAc measurements of RTV were broken down into quartiles and analyzed for visual- and treatment burden-related outcomes.

Results : The percent of eyes with a CST ≤300 µm fluctuated throughout the 36 months post-FAc but was significantly increased relative to baseline. At its peak, 55.4% of eyes had CST ≤300 µm, which occurred at month 21, compared to 32.9% at baseline, and at month 36, 46.9% of eyes had CST ≤300 µm (P<0.05). FAc significantly reduced RTV in all measures (CST-AUC, RTA, RTSD) over 36 months (P<0.0001). Visual outcomes as measured by the last observed BCVA (letters) exhibited linear correlations with CST-AUC (R2= -0.448), RTA (R2= -0.432), and RTSD (R2= -0.436). When divided into quartiles, the eyes with the best control of RTV post-FAc, quartile 1 (Q1), had the greatest gains in BCVA compared to baseline (CST-AUC Q1=+6.8 letters; RTA Q1=+5.1 letters; RTSD Q1=+7.9 letters; p-values <0.05) and improved their disease control as measured by the need for less supplemental therapy.

Conclusions : FAc treatment significantly improved RTV as evidenced by significant reductions in CST-AUC, RTA, and RTSD and were correlated with significant improvements in vision when compared to the results from standard of care in the months preceding FAc treatment. These data support that treatment with the 0.19 mg FAc implant may lead to long-term control of RTV which is a positive prognostic indicator of visual acuity- and treatment burden-related outcomes in patients with DME.

This abstract was presented at the 2023 ARVO Annual Meeting, held in New Orleans, LA, April 23-27, 2023.

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