Abstract
Purpose :
Uveitis describes a heterogeneous group of diseases characterized by intraocular inflammation due to either infectious or non-infectious causes. Non-infectious uveitis (NIU) often requires sustained, long-duration therapy, either systemic or local. The fluocinolone acetonide intravitreal (FAi) insert (0.18) is used to treat chronic, non-infectious posterior uveitis by delivering a low-dose, sustained release of FA for up to 36 months. The purpose of this study is to describe the outcomes of the FAi in treating NIU in a real-world database.
Methods :
A phase IV, web-based registry system was developed to capture patients treated with the FAi insert from multiple clinical sites, to assess the impact on ocular inflammation using OCT imaging, fluorescein angiography, and visual acuity endpoints. Visual acuity was converted from Snellen equivalent to ETDRS. Safety details, including intraocular pressure and glaucoma interventions, were collected and summarized.
Results :
Eight sites have contributed data for 149 eyes of 115 patients with a mean (± standard deviation [SD]) age of 63.7 ± 12.6 (range 19 to 90) to the registry. 60% of the patients are female and 70% are white. The majority of eyes (79.2%) were treated for either posterior or panuveitis. Mean OCT thickness at the time of study entry was 374.1 ± 159.4 microns and average VA was 57.9 ± 25.0 letters. OCT central subfield thickness measurements indicate that 42% of the eyes had a dry central retina at the time of implant. That number increased to 55% at 6 months. 55% of eyes had 20/50 or better visual acuity at baseline and that number increased to 60% at 6 months. Mean baseline IOP was 13.8 ± 4.6 mmHg (range 5 to 30) and increased 1.0 ± 4.9 mm Hg on average at 6 months. The retrospective database will remain open for up to 5 years.
Conclusions :
Preliminary data in the CALM registry database indicate effective control of non-infectious uveitis, with improved visual acuity outcomes and without major safety signals. Additional data will be needed to validate these short-term results.
This abstract was presented at the 2022 ARVO Annual Meeting, held in Denver, CO, May 1-4, 2022, and virtually.