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

NCT03919019 | Completed DMC

• 1 other identifier: RET 04 2017
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Dry AMD

Keywords

oral supplementation; mfERG; OCT

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

Macuprev Group

EXPERIMENTAL

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

Other: Macuprev Group

Placebo Group

PLACEBO COMPARATOR

patients taking oral placebo 2 capsules per day for 6 months

Other: Placebo Group

Interventions

Macuprev Group OTHER

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

Macuprev Group

Placebo Group OTHER

oral placebo 2 capsules per day for 6 months

Placebo Group

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione G.B. Bietti, IRCCS: lead

Study Sites (1)

Fondazione G.B.Bietti

Roma, 00135, Italy

Location

Related Publications (4)

• 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.

  PMID: 17846363 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.

  PMID: 17716735 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.

  PMID: 22009916 BACKGROUND

• 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.

  PMID: 31243641 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head Retina Unit

Model Details: monocentric, prospective, double blind randomized six months study

Study Record Dates

• First Submitted: February 14, 2019
• First Posted: April 18, 2019
• Study Start: January 18, 2018
• Primary Completion: October 19, 2018
• Study Completion: November 20, 2018
• Last Updated: May 9, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)