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Advances in Therapy

, Volume 36, Issue 9, pp 2493–2505 | Cite as

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

  • Mariacristina Parravano
  • Massimiliano Tedeschi
  • Daniela Manca
  • Eliana Costanzo
  • Antonio Di Renzo
  • Paola Giorno
  • Lucilla Barbano
  • Lucia ZiccardiEmail author
  • Monica Varano
  • Vincenzo Parisi
Brief Report

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 mfERG OCT Ophthalmology 

Notes

Acknowledgements

We thank the participants of the study. The authors also acknowledge Dr. Valter Valli Fiore for his technical help in the electrophysiological evaluations.

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.

Authorship

All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published.

Disclosures

Mariacristina Parravano, Massimiliano Tedeschi, Daniela Manca, Eliana Costanzo, Antonio Di Renzo, Paola Giorno, Lucilla Barbano, Lucia Ziccardi, Monica Varano, and Vincenzo Parisi have nothing to disclose.

Compliance with Ethics Guidelines

The study was registered at ClinicalTrials.gov (NCT03919019) and was approved by the local ethics committee (Comitato Etico Centrale IRCCS Lazio, Sezione IFO/Fondazione Bietti, Rome, Italy—Registro Sperimentazioni Italiano approval number 59/17/FB). All procedures performed in this study were also in accordance with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. Informed consent was obtained from all individual participants included in the study.

Data Availability

All authors had full access to all of the data in this study and take complete responsibility for the integrity of the data and accuracy of the data analysis. The data sets generated and/or analyzed during the current study are available from the corresponding author on reasonable request.

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Copyright information

© Springer Healthcare Ltd., part of Springer Nature 2019

Authors and Affiliations

  • Mariacristina Parravano
    • 1
  • Massimiliano Tedeschi
    • 1
  • Daniela Manca
    • 1
  • Eliana Costanzo
    • 1
  • Antonio Di Renzo
    • 1
  • Paola Giorno
    • 1
  • Lucilla Barbano
    • 1
  • Lucia Ziccardi
    • 1
    Email author
  • Monica Varano
    • 1
  • Vincenzo Parisi
    • 1
  1. 1.IRCCS Fondazione BiettiRomeItaly

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