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

Fondazione G.B. Bietti, IRCCS

Status: Completed

Conditions: Dry AMD

Treatments: Other: Placebo Group; Other: Macuprev Group

Study type: Interventional

Funder types: Other

Identifiers

NCT03919019

RET 04 2017

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 2 patient groups, including a placebo group

Macuprev Group

Experimental group

Description:

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

Treatment:

Other: Macuprev Group

Placebo Group

Placebo Comparator group

Description:

patients taking oral placebo 2 capsules per day for 6 months

Treatment:

Other: Placebo Group