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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Macuprev Group | Experimental | patients taking oral supplementation (Macuprev) 2 capsules per day for 6 months |
|
| Placebo Group | Placebo Comparator | patients taking oral placebo 2 capsules per day for 6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Macuprev Group | Other | oral supplementation (Macuprev) 2 capsules per day for 6 months |
| |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione G.B.Bietti | Roma | 00135 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17846363 | Background | 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. doi: 10.1001/archopht.125.9.1225. | |
| 17716735 |
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monocentric, prospective, double blind randomized six months study
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| Placebo Group |
| Other |
oral placebo 2 capsules per day for 6 months |
|
| Morpho-functional retinal relationships after 6 months follow up |
| Background |
| 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. doi: 10.1016/j.ophtha.2007.05.029. Epub 2007 Aug 22. |
| 22009916 | Background | 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. |
| 31243641 | Derived | Parravano M, Tedeschi M, Manca D, Costanzo E, Di Renzo A, Giorno P, Barbano L, Ziccardi L, Varano M, Parisi V. Effects of Macuprev(R) Supplementation in Age-Related Macular Degeneration: A Double-Blind Randomized Morpho-Functional Study Along 6 Months of Follow-Up. Adv Ther. 2019 Sep;36(9):2493-2505. doi: 10.1007/s12325-019-01016-2. Epub 2019 Jun 25. |