Evaluation of the anti-inflammatory efficacy of high oral bioavailability Curcumin as add-on treatment in non-infectious uveitic cystoid macular edema by SD-OCT and OCT-Angiography: preliminary results

Abstract

Purpose : To investigate the efficacy and safety of a curcumin formulation with hydrophilic carrier (CHC; Diabec® - AlfaIntes, Italy) as an adjuvant treatment in adults suffering from recent onset of non-infectious inflammatory cystoid macular edema (CME).

Methods : A monocentric parallel group clinical study was carried out from March to November 2019, including a control group (standard therapy) and a curcumin add-on treatment group (standard therapy + Diabec^®). According to the protocol, one capsule twice a day of Diabec^® was administered for six months in association with standard systemic therapy (oral prednisone 15 mg/day and/or methotrexate 15 mg/week) in the curcumin-treatment study group. Reduction in central foveal thickness (CFT) assessed by Heidelberg Spectralis OCT and best-corrected visual acuity (BCVA - ETDRS charts) were the main analysed outcomes. Secondary end-point was the evaluation of the Foveal Avascular Zone (FAZ) variations with Optovue AngioVue angiography, before and after 6 months.

Results : Forty-eight eyes of 26 patients (17 females and 9 males, mean age 53.4 years +1.3 months) were included into the study, with an average follow-up (f/u) of 6 months ±1 week. Eighteen patients were affected by posterior uveitis, 3 by pan-uveitis and 5 by intermediate uveitis, evenly distributed between the two groups. In the curcumin-treated group (25 eyes) CFT gap from T₀ to T₆ was significant (p < 0.05) and CFT decreased from 320 μm (± 96.7) to 283 μm (± 46.3). Control group (23 eyes) showed no variations in CFT (T₀=299±71 μm and T₆=282 ± 51). Mean visual acuity improvement at T₆ was 5.8 ETDRS letters in the experimental treatment group (p<0.01). No significant difference in 6 months was registered in the control group. No adverse events were recorded.

Conclusions : An oral formulation of curcumin in hydrophilic carrier (CHC; Diabec®) as adjuvant treatment resulted statistically effective and safe at 6 months in eyes affected by recent onset non-infectious inflammatory CME. These patients showed an anatomical and functional improvement compared to the standard therapy control group. These preliminary results will be assessed at 12 months.

This is a 2020 ARVO Annual Meeting abstract.