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

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Dry AMD

Intervention / Treatment
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* Other: Macuprev Group
* Other: Placebo Group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: monocentric, prospective, double blind randomized six months study
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Macuprev Group<br>patients taking oral supplementation (Macuprev) 2 capsules per day for 6 months | Other: Macuprev Group<br>* oral supplementation (Macuprev) 2 capsules per day for 6 months<br>|
| Placebo Comparator: Placebo Group<br>patients taking oral placebo 2 capsules per day for 6 months | Other: Placebo Group<br>* oral placebo 2 capsules per day for 6 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Multifocal electroretinogram (mfERG) in patients with dry age-related macular degeneration 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 | Functional retinal changes after 6 months follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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) | Morpho-functional retinal relationships after 6 months follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oral supplementation, mfERG, OCT