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

Overview

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.

Full Title of Study: “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)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: October 19, 2018

Interventions

  • Other: Macuprev Group
    • oral supplementation (Macuprev) 2 capsules per day for 6 months
  • Other: Placebo Group
    • oral placebo 2 capsules per day for 6 months

Arms, Groups and Cohorts

  • Experimental: Macuprev Group
    • patients taking oral supplementation (Macuprev) 2 capsules per day for 6 months
  • Placebo Comparator: Placebo Group
    • patients taking oral placebo 2 capsules per day for 6 months

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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)

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 50 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Fondazione G.B. Bietti, IRCCS
  • Provider of Information About this Clinical Study
    • Principal Investigator: Mariacristina Parravano, Head Retina Unit – Fondazione G.B. Bietti, IRCCS

References

Age-Related Eye Disease Study Research Group, SanGiovanni JP, Chew EY, Clemons TE, Ferris FL 3rd, Gensler G, Lindblad AS, Milton RC, Seddon JM, Sperduto RD. The relationship of dietary carotenoid and vitamin A, E, and C intake with age-related macular degeneration in a case-control study: AREDS Report No. 22. Arch Ophthalmol. 2007 Sep;125(9):1225-32.

Parisi V, Tedeschi M, Gallinaro G, Varano M, Saviano S, Piermarocchi S; CARMIS Study Group. Carotenoids and antioxidants in age-related maculopathy italian study: multifocal electroretinogram modifications after 1 year. Ophthalmology. 2008 Feb;115(2):324-333.e2. Epub 2007 Aug 22.

Piermarocchi S, Saviano S, Parisi V, Tedeschi M, Panozzo G, Scarpa G, Boschi G, Lo Giudice G; Carmis Study Group. Carotenoids in Age-related Maculopathy Italian Study (CARMIS): two-year results of a randomized study. Eur J Ophthalmol. 2012 Mar-Apr;22(2):216-25. doi: 10.5301/ejo.5000069.

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