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OpenTrials
Completed

NCT Number: NCT03919019

Morpho-functional Changes After Oral Supplementation of Antioxidants and Anti-inflammatory Treatment in Age-Related Macular Degeneration.

In patients with AMD a deterioration of the antioxidant mechanisms of the retina is observed and therefore an increase in the production of free radicals responsible for tissue damage.

The Age-Related Eye Disease Study (AREDS) found that the intake of antioxidants reduces the risk of progression of the disease to an advanced stage (choroidal neovascularization or geographic atrophy ) and reduces the loss of visual acuity.

In this study the investigators want to analyze the functional retinal changes (mfERG) of the macular region, in patients with dry age-related macular degeneration, after the use for 6 months of an oral supplementation based on Ganoderma lucidum (Reishi), Calendula Officinalis, Lutepure-Marigold ( 5% Lutein and 1% Zeaxanthin) Blueberry, Rutin, Alpha-lipoic acid, Bromelain, NAC, Vtiamine C, B9, B12, D3, Selenium, Zinc and Copper.

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Key information

Conditions

Dry AMD

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione G.B.Bietti

Roma, 00135, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age> 50;
  • dry AMD not in therapy with oral supplements or antioxidants
  • visual acuity ≥ 20/40
  • ability to provide written informed consent and to follow the procedures of the study;

Exclusion criteria

  • spherical refractive error greater than ±6 diopters
  • cylindrical refractive error greater than ±3 dioptres
  • opacity of diopter means
  • any active or past retinal pathology other than AMD
  • history of ocular surgery (<6 months)
  • Pregnancy

Treatment and study plan

Macuprev Group

Other

oral supplementation (Macuprev) 2 capsules per day for 6 months

Placebo Group

Other

oral placebo 2 capsules per day for 6 months

Primary outcomes

  1. Change of Multifocal electroretinogram (mfERG) in patients with dry age-related macular degeneration after 6 months follow up

    Time frame: Functional retinal changes after 6 months follow up

    To evaluate functional retinal changes of the macular region by multifocal electroretinogram in patients with dry age-related macular degeneration after the use for 6 months of an oral supplementation in tablets based on Ganoderma lucidum (Reishi), Calendula Officinalis, Lutepure-Marigold ( 5% Lutein and 1% Zeaxanthin) Blueberry, Rutin, Alpha-lipoic acid, Bromelain, NAC, Vtiamine C, B9, B12, D3, Selenium, Zinc and Copper.

    The researchers analyzed the average response amplitude densities (RAD: nanoV/ degree 2) between the first negative peak, N1 and the first positive peak, P1

Secondary outcomes

  1. To evaluate correlation between mfERG changes (functional activity) and morphological retinal changes (CRT: central retinal thickness and VD: vessel density at the superficial and deep capillary plexa) after 6 months follow up

    Time frame: Morpho-functional retinal relationships after 6 months follow up

    The researchers evaluated the linear relationships between the mfERG (Response Amplitude Density (RAD nanoV/degree2) and OCT/OCTA values (CRT in micron and vessel density in mm3) by Pearson's Test after administration of a oral supplementation (Macuprev)

Sponsors and collaborators

Lead sponsor

Fondazione G.B. Bietti, IRCCS

Other

Registry information

Official study title

Evaluation of Macular Function and Related Changes in Visual Perception and Retinal Morphology After 6 Months of Use of Oral Supplementation Called MACUPREV, in Patients With Dry Age-related Macular Degeneration (AMD)

Acronym: MACUPREV

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Apr 18, 2019
Registry last updated
May 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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