Clinical effectiveness of a new oral curcumin formulation in acute non-infectious uveitic macular edema: a 12-month observational study.

Abstract

Oral supplementation with curcumin demonstrated a beneficial effect on some ocular diseases, including uveitis and macular edema. This study aimed to evaluate the effectiveness and safety of a curcumin formulation with the hydrophilic carrier (CHC; Diabec®, Alfa Intes, Italy) as an adjuvant to standard steroid treatment in adults suffering from acute non-infectious uveitic macular edema (NIUME). This was a monocenter prospective observational study carried out between January 2019 and May 2020 on consecutive patients with a new diagnosis of NIUME. Patients were treated with standard therapy or with a CHC add-on to standard treatment. The observation period for each patient was 12 months. The Best Corrected Visual Acuity (BCVA) and the Central Macular Thickness (CMT) were the primary outcomes; Foveal Avascular Zone (FAZ) and intraocular pressure (IOP) were also assessed, along with safety data. A total of 43 eyes of 26 patients were analyzed. CHC-treated eyes showed an improvement in mean BCVA from baseline (0.34 logMar) to T6 (0.20 logMar) and T12 (0.19 logMar; p≤0.05 and p≤0.01, respectively); CMT decreased from a mean of 320 μm (T0) to 278 μm (T6; p≤0.05) and 272 μm (T12; p≤0.01). A significant improvement of mean BCVA in the CHC group at T6 and T12 was reported compared to the control group (p≤0.01). FAZ and IOP showed no statistically significant variations in both groups. No adverse events were recorded. CHC as an adjuvant treatment improved the anatomical and functional outcomes, without significant side effects in eyes affected by the recent onset of NIUME, compared to the sole standard therapy.