Investigative Ophthalmology & Visual Science Cover Image for Volume 65, Issue 7
June 2024
Volume 65, Issue 7
Open Access
ARVO Annual Meeting Abstract  |   June 2024
CALM: 24-month safety outcomes from a real-world registry study of patients with chronic non-infectious uveitis affecting the posterior segment treated with the 0.18 mg fluocinolone acetonide intravitreal implant
Author Affiliations & Notes
  • Tedi Begaj
    Department of Ophthalmology, Corewell Health Beaumont Hospital, Royal Oak, Michigan, United States
  • Lisa Faia
    Department of Ophthalmology, Corewell Health Beaumont Hospital, Royal Oak, Michigan, United States
  • Footnotes
    Commercial Relationships   Tedi Begaj Eyepoint, RegenXbio, Alimera, Code C (Consultant/Contractor); Lisa Faia Janssen, AbbVie/Allergan, Iveric Bio, Alimera, Genentech/Roche, Bausch + Lomb, Code C (Consultant/Contractor)
  • 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 2024, Vol.65, 3011. doi:
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      Tedi Begaj, Lisa Faia; CALM: 24-month safety outcomes from a real-world registry study of patients with chronic non-infectious uveitis affecting the posterior segment treated with the 0.18 mg fluocinolone acetonide intravitreal implant. Invest. Ophthalmol. Vis. Sci. 2024;65(7):3011.

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

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Abstract

Purpose : To analyze real-world outcomes among patients with chronic non-infectious uveitis affecting the posterior segment (NIU-PS) receiving the 0.18 mg fluocinolone acetonide intravitreal implant (FAc).

Methods : Eligible patients were ≥18 years of age, diagnosed with chronic NIU-PS, and did not have contraindications to the FAc implant. Primary and secondary outcomes included recurrence of uveitis, change in optical coherence tomography (OCT) parameters, and visual acuity. Safety data included intraocular pressure (IOP) elevation and rates of surgical interventions.

Results : A total of 243 eyes from 182 patients received the FAc implant (mean age 63.2 years; 69% white; 65% female). Most cases of NIU-PS were idiopathic; sarcoidosis was the 2nd most common specified etiology. More than 85% of eyes were treated for posterior or panuveitis. Through 24 months, 96.7% received a single FAc implant, 2.9% of eyes received two implants, and 0.4% received three implants. Baseline median IOP was 14.0 mmHg and remained stable through 24 months (14.5 mmHg). The proportion of eyes with IOP increases >10 mmHg from baseline was 12.3%, while 4.5% had an IOP measurement of >30 mmHg. Through 24 months, 1.2% of eyes had laser trabeculoplasty, and 3.3% had incisional surgery to control IOP, including trabeculectomy (1.2%) and tube implantation (2.1%). No cataract surgeries were reported.

Conclusions : Data from the CALM real-world registry study indicate effective control of chronic NIU-PS with the FAc 0.18 mg implant and IOP outcomes comparable to those reported in randomized, controlled clinical trials.

This abstract was presented at the 2024 ARVO Annual Meeting, held in Seattle, WA, May 5-9, 2024.

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