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

Dry AMD Clinical Trial

— MACUPREV  

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03919019
• Other study ID #: RET 04 2017
• Status: Completed
• Phase: N/A
• Start date: January 18, 2018
• Est. completion date: November 20, 2018

Study information

• Verified date: May 2019
• Source: Fondazione G.B. Bietti, IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 20, 2018
• Est. primary completion date: October 19, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Dry AMD
• Macular Degeneration

Intervention

Other:
• Macuprev Group
oral supplementation (Macuprev) 2 capsules per day for 6 months
• Placebo Group
oral placebo 2 capsules per day for 6 months

Locations

Country	Name	City	State
Italy	Fondazione G.B.Bietti	Roma

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione G.B. Bietti, IRCCS

Country where clinical trial is conducted

Italy, 

References & Publications (3)

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. — View Citation

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. Epub 2007 Aug 22. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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