Affiliation:
1. Clínic Hospital of Barcelona
2. Hospital Fundacion Jiménez Díaz
3. CIICESI, ESTG
Abstract
Abstract
Purpose This assessed the effectiveness of the 0.19 mg fluocinolone acetonide (FAc) implant by multimodal measurements in patients with non-infectious uveitis (NIU) in a real-world setting in Spain.Methods A prospective study of patients who had NIU including uveitic macular oedema (UME) with ≥ 12 months follow-up was done. Exclusion criteria include infectious uveitis and uncontrolled glaucoma or ocular hypertension requiring more than 2 medications. Effectiveness was assessed using a multicomponent outcome measure that included nine outcomes, with effectiveness defined as all components being met at every timepoint. Secondary outcome measures: onset or progression of glaucoma and investigator-reported adverse events.Results Twenty-six eyes from 22 patients were included, with 96.2% having an indication including UME. During the 12-month study, the FAc implant was effective in 15 (57.7%) eyes, reaching effectiveness as soon as 2 weeks post-implantation. Mean best-corrected visual acuity and mean central macular thickness (CMT) were significantly improved vs. baseline at all timepoints (all comparisons p < 0.01). During the 12-month study, markers of inflammation (anterior chamber cells and vitreous haze) also significantly declined. Factors predicting effectiveness at month 12: systemic corticosteroid dose pre-FAc, higher immunomodulatory therapy (IMT) load at baseline and thicker retinal nerve fiber layer (RNFL) at baseline (all p < 0.05). Factors predicting failure: male, thinner RNFL at baseline and treatment ineffective at 1 month (all p < 0.05). In parallel, corticosteroid and IMT use also declined significantly. No significant increases in IOP.Conclusion The FAc implant is safe and effective at treating NIU over 12 months in a real-world setting in Spain.
Publisher
Research Square Platform LLC