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

Not Applicable

Completed

• Conditions: Dry AMD
• Interventions: Other: Placebo Group; Other: Macuprev Group

• Registration Number: NCT03919019
• Lead Sponsor: Fondazione G.B. Bietti, IRCCS

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-18
• Primary Completion: 2018-10-19
• Study Completion: 2018-11-20
• Study First Submitted: 2019-02-14
• Study First Submitted QC: 2019-04-16
• Study First Posted: 2019-04-18
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-07
• Last Update Posted: 2019-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Group	Placebo Group	patients taking oral placebo 2 capsules per day for 6 months
Macuprev Group	Macuprev Group	patients taking oral supplementation (Macuprev) 2 capsules per day for 6 months

Primary Outcome Measures

Name	Time	Method
Change of Multifocal electroretinogram (mfERG) in patients with dry age-related macular degeneration after 6 months follow up	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 Outcome Measures

Name	Time	Method
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	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)

Trial Locations

Locations (1)

Fondazione G.B.Bietti; 🇮🇹 Roma, Italy