June 2023
Volume 64, Issue 8
Open Access
ARVO Annual Meeting Abstract  |   June 2023
CALM: A retrospective registry to characterize clinical outcomes for chronic non-infectious posterior segment uveitis patients treated with the 0.18 mg fluocinolone acetonide intravitreal implant: Retinal Anatomical Outcomes
Author Affiliations & Notes
  • Alison Zhao
    Cleveland Clinic Lerner College of Medicine of Case Western Reserve University, Cleveland, Ohio, United States
  • Kanika Seth
    Cleveland Clinic Cole Eye Institute, Cleveland, Ohio, United States
  • James Bena
    Cleveland Clinic Department of Quantitative Health Sciences, Cleveland, Ohio, United States
  • Shannon Morrison
    Cleveland Clinic Department of Quantitative Health Sciences, Cleveland, Ohio, United States
  • Rishi Singh
    Cleveland Clinic Cole Eye Institute, Cleveland, Ohio, United States
    Cleveland Clinic Martin Health, Stuart, Florida, United States
  • Sumit Sharma
    Cleveland Clinic Cole Eye Institute, Cleveland, Ohio, United States
  • Footnotes
    Commercial Relationships   Alison Zhao None; Kanika Seth None; James Bena None; Shannon Morrison None; Rishi Singh Genentech/Roche, Alcon, Novartis, Regeneron, Asclepix, Gyroscope, Bausch + Lomb, Apellis, Code I (Personal Financial Interest); Sumit Sharma AbbVie, Bausch + Lomb, EyePoint, Regeneron, Genentech/Roche, Clearside, Code C (Consultant/Contractor), Gilead, Genentech/Roche, Santen, IONIS, Code F (Financial Support)
  • Footnotes
    Support  This study was supported by a grant by Eyepoint and in part by an unrestricted institutional grant from Fight for Sight.
Investigative Ophthalmology & Visual Science June 2023, Vol.64, 3560. doi:
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      Alison Zhao, Kanika Seth, James Bena, Shannon Morrison, Rishi Singh, Sumit Sharma; CALM: A retrospective registry to characterize clinical outcomes for chronic non-infectious posterior segment uveitis patients treated with the 0.18 mg fluocinolone acetonide intravitreal implant: Retinal Anatomical Outcomes. Invest. Ophthalmol. Vis. Sci. 2023;64(8):3560.

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

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Abstract

Purpose : Non-infectious uveitis is a leading cause of preventable blindness, with chronicity and high recurrence. Vision loss associated with this condition is often due to fluid accumulation in the layers of the retina, which can be measured using optical coherence tomography imaging (OCT). Conventional systemic and local corticosteroid treatments are associated with significant systemic side effects and risk of ocular injury. Intravitreal implants, such as the 0.18 mg fluocinolone acetonide implant (FAi), achieve sustained low-dose drug delivery for up to 36 months. There are few real-world studies measuring the therapeutic performance of this FAi. This study aims to assess changes in edematous status following FAi implementation via characterization of retinal thickness parameters.

Methods : Retrospective analysis was conducted on 134 eyes from 122 patients in the CALM registry, a phase IV web-based database following patients treated with the FAi at 16 U.S. sites. Patient demographics (sex, age, race/ethnicity) were collected at baseline. At baseline and 3-, 6-, 9-, and 12 months post-implantation, anatomical biomarkers characterizing macular edema, such as central subfield thickness (CST), cube average thickness (CAT), and cube volume (CV), were assessed on OCT. Best corrected visual acuity (BCVA) was assessed at above timepoints and converted from Snellen equivalent to EDTRS. Wilcoxon signed rank tests and linear mixed effect models were used to evaluated change from baseline.

Results : Mean (± SD) patient age was 63.3 ± 12.8 years. 74% of patients are female, and 87% are white. Median CST, CAT, and CV were 324 µm, 332 µm, and 9.08 mm3 at baseline, and 299 µm, 323 µm, and 8.66 mm3 at 12 months, respectively. Absolute reduction in CST, CAT, and CV from baseline was significant at all subsequent timepoints (all p≤0.01). Mixed linear effects models indicated that increases in BCVA were significant at 3 months, 9 months, and 12 months post-implantation (all p<0.05).

Conclusions : The present analysis suggests that the 0.18 mg FAi effectively reduces macular edema and improves visual acuity in patients with non-infectious uveitis. Longitudinal follow-up is needed to assess maintenance of fluid reduction at later timepoints.

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

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