Efficacy and safety of fluocinolone acetonide intravitreal implant (0.2 µg/day) in patients with post-surgical inflammation associated with macular edema: a case series study.

Abstract

Background: Postoperative cystoid macular edema (PCME) is a primary cause of reduced vision following both cataract and/or vitreoretinal surgery, which may spontaneously resolve. This study aimed to evaluate the effectiveness and safety of the fluocinolone acetonide intravitreal (FAc) implant (0.2 µg/day) in patients with refractory PCME.

Methods: Retrospective, non-interventional, and single center study conducted on patients with PCME treated with 0.2 µg/day FAc implant. All the patients received previous treatment with topical corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDs), triancinolone injection and dexamethasone implant. The primary end-points were the mean change in best-corrected-visual-acuity (BCVA) and the proportion of patients gaining ≥ 15 letters from baseline to the last follow-up visit. The secondary endpoints included the mean CRT reduction and the mean intraocular pressure (IOP) during the 36 months study period.

Results: Eight eyes from 8 patients were included in the study. Median (95% Confidence-interval) BCVA was significantly improved from 60.0 (50.05-69.95) letters at baseline to 80.15 (77.25-85.00) letters at month-36, p = 0.043. At the last follow-up visit, 5 (62.5%) eyes gained ≥ 15 letters, without any eye experiencing a loss of BCVA compared to baseline. There was significant CRT reduction from baseline (median: 497.5 μm; 95%CI: 380.0-596.0 μm) to month-36 (Median: 252.0 μm; 95%CI: 242.0-268.0 μm); p = 0.012. Regarding safety, IOP remained stable from baseline (median: 14.5mmHg; 95%Confidence-interval: 12.0-23.0 mmHg) to the last follow-up visit (median: 13.5mmHg; 95% Confidence-interval: 9.0-19.0 mm Hg); p = 0.123.

Conclusions: The FAc implant significantly improved both visual and anatomic outcomes, and was effective in preventing recurrences, while maintaining a reasonable safety profile, in PCME refractory to intravitreal triancinolone and dexamethasone.