Morpho-functional Changes After Oral Supplementation of Antioxidants and Anti-inflammatory Treatment in Age-Related Macular Degeneration.
NCT ID: NCT03919019
Last Updated: 2019-05-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2018-01-18
2018-11-20
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Macuprev Group
patients taking oral supplementation (Macuprev) 2 capsules per day for 6 months
Macuprev Group
oral supplementation (Macuprev) 2 capsules per day for 6 months
Placebo Group
patients taking oral placebo 2 capsules per day for 6 months
Placebo Group
oral placebo 2 capsules per day for 6 months
Interventions
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Macuprev Group
oral supplementation (Macuprev) 2 capsules per day for 6 months
Placebo Group
oral placebo 2 capsules per day for 6 months
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
50 Years
80 Years
ALL
No
Sponsors
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Fondazione G.B. Bietti, IRCCS
OTHER
Responsible Party
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Mariacristina Parravano
Head Retina Unit
Locations
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Fondazione G.B.Bietti
Roma, , Italy
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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RET 04 2017
Identifier Type: -
Identifier Source: org_study_id
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