Effects of Macuprev® Supplementation in Age-Related Macular Degeneration: A Double-Blind Randomized Morpho-Functional Study Along 6 Months of Follow-Up

Abstract

Background: To evaluate the effects of Macuprev^® supplementation on macular function and structure in intermediate age-related macular degeneration (AMD) along 6 months of follow-up.

Methods: In this double-blind, monocentric, randomized, and prospective study, 30 patients with intermediate AMD were enrolled and randomly divided into two age-similar groups: 15 patients (AMD-M group; mean age 68.50 ± 8.79 years) received 6-month oral daily supplementation with Macuprev^® (Farmaplus Italia s.r.l., Italy, two tablets/day on an empty stomach, before meals; contained in total lutein 20 mg, zeaxanthin 4 mg, N-acetylcysteine 140 mg, bromelain 2500GDU 80 mg, vitamin D₃ 800 IU, vitamin B₁₂ 18 mg, alpha-lipoic acid 140 mg, rutin 157 mg, vitamin C 160 mg, zinc oxide 16 mg, Vaccinium myrtillus 36% anthocyanosides 90 mg, Ganoderma lucidum 600 mg) and 15 patients (AMD-P group; mean age 70.14 ± 9.87) received two tablets of placebo daily on an empty stomach, before meals. A total of 28 eyes, 14 from each AMD group, completed the study. Multifocal electroretinogram (mfERG) and spectral domain-optical coherence tomography (SD-OCT) were assessed at baseline and after 6 months.

Results: At 6-month follow-up, AMD-M eyes showed a significant increase of mfERG response amplitude density (RAD) recorded from the central macular areas (ring 1, 0-2.5°; ring 2, 2.5-5°), whereas non-significant changes of retinal and choroidal SD-OCT parameters were found when values were compared to baseline. Non-significant correlations between functional and structural changes were found. In AMD-P eyes, non-significant differences for each mfERG and SD-OCT parameters were observed at 6 months.

Conclusions: In intermediate AMD, Macuprev^® supplementation increases the function of the macular pre-ganglionic elements, with no associated retinal and choroidal ultra-structural changes.

Trial registration: ClinicalTrials.gov identifier, NCT03919019.

Funding: Research for this study was financially supported by the Italian Ministry of Health and Fondazione Roma. Article processing charges were funded by Farmaplus Italia s.r.l., Italy.

Keywords: Carotenoid and antioxidant supplementation; Intermediate age-related macular degeneration; OCT; Ophthalmology; mfERG.

Fig. 1

Examples of multifocal electroretinogram (mfERG) tri-dimensional plots, recorded from six eyes with intermediate age-related macular degeneration (AMD) at baseline and after 6-month follow-up. AMD patients were treated with placebo (AMD-P eyes) or with Macuprev^® (AMD-M eyes). At 6 months, with respect to baseline, the tri-dimensional plot in AMD-P eyes showed unmodified or worsened central localized amplitudes, whereas AMD-M eyes showed improved central localized amplitudes

Fig. 2

Individual changes after 6-month follow-up with respect to baseline of multifocal electroretinogram (mfERG) R1–R5 N1–P1 response amplitude density (RAD) values observed in AMD eyes treated with placebo (AMD-P eyes) or treated with Macuprev^® (AMD-M eyes). R1–R5 refers to localized mfERG responses averaged in five eccentricity areas between the fovea and mid-periphery: 0–2.5° (R1), 2.5–5° (R2), 5–10° (R3), 10–15° (R4), and 15–20° (R5). The percentage of unmodified eyes (within the 95% confidence test–retest limit—values within solid and dashed line), eyes with improvement (values over the 95% confidence test–retest limit—solid line), and eyes with worsening (values under the 95% confidence test–retest limit—dashed line) are reported in Table 2