Oral administration of a curcumin-phospholipid delivery system for the treatment of central serous chorioretinopathy: a 12-month follow-up study

Fabio Mazzolani, Stefano Togni, Fabio Mazzolani, Stefano Togni

Abstract

Background: The therapeutic effects of Meriva®, a curcumin-phospholipid (lecithin) delivery system (formulated as Norflo® tablets), on visual acuity and retinal thickness in patients with acute and chronic central serous chorioretinopathy was previously investigated in a six-month open-label study.

Methods: In this follow-up study, visual acuity was again assessed by ophthalmologic evaluation and retinal thickness by optical coherence tomography (OCT). Norflo tablets were administered twice daily to patients with central serous chorioretinopathy. The study group consisted of 12 patients (total 18 eyes) who completed 12 months of follow-up. The primary endpoint was change in visual acuity before and after treatment with Norflo, and change in neuroretinal or retinal pigment epithelium detachment on OCT was the secondary endpoint.

Results: After 12 months of therapy, no eyes showed further reduction in visual acuity, 39% showed stabilization, and 61% showed statistically significant improvement (P = 0.0001 by Student's t-test and P = 0.0005 by Wilcoxon signed rank test). Ninety-five percent of eyes showed a reduction in neuroretinal or retinal pigment epithelium detachment and 5% showed stabilization. The difference in retinal thickness after 12 months was statistically significant (P = 0.0001 by Student's t-test and P = 0.0004 by Wilcoxon signed rank test).

Conclusion: These results, albeit preliminary, confirm our previous finding that this curcumin delivery system is effective in the management of central serous chorioretinopathy. When administered in a bioavailable formulation, curcumin is worth considering as a therapeutic agent for the management of inflammatory and degenerative eye conditions involving activation of retinal microglial cells.

Keywords: Meriva®; Norflo®; central serous chorioretinopathy; curcumin; retinal pigment epithelium detachment.

Figures

Figure 1
Figure 1
(A) Effect of the curcumin-lecithin formulation (Norflo®) on visual acuity after six months of treatment. (B) The notched box plot shows the confidence interval around the median, which is normally based on the median ± 1.57 × interquartile range/square root of n. According to this graphical method for data analysis, if the notches of the two boxes do not overlap, there is “strong evidence” (95% confidence) that their medians differ. Points outside the whisker boundaries are considered outliers (green = mild). Note: Norflo®, Eye Pharma, genova, Italy.
Figure 2
Figure 2
(A) Effect of the curcumin-lecithin formulation (Norflo®) on OCT retinal thickness after 12 months of treatment (B) The notched box plot displays the confidence interval around the median which is normally based on the median ± 1.57 × interquartile range/square root of n. According to the graphical methods for data analysis, if two boxes’ notches do not overlap there is ‘strong evidence’ (95% confidence) that their medians differ. Points outside the whisker boundaries are considered outliers (green = mild). Abbreviation: OCT, optical coherence tomography. Note: Norflo®, Eye Pharma, genova, Italy.
Figure 3
Figure 3
Effect of the curcumin-lecithin formulation (Norflo®) on OCT retinal thickness after 12 months. The images represent three different cases (from left to right, 1–3), evaluated at different times (at first visit, A, and at follow up, B). The green line identifies the area analyzed in cross sectional mode and reported in the image on the right. Abbreviation: OCT, optical coherence tomography. Note: Norflo®, Eye Pharma, genova, Italy.

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