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Trial record 73 of 183 for:    RET

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

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ClinicalTrials.gov Identifier: NCT03919019
Recruitment Status : Completed
First Posted : April 18, 2019
Last Update Posted : May 9, 2019
Sponsor:
Information provided by (Responsible Party):
Mariacristina Parravano, 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.


Condition or disease Intervention/treatment Phase
Dry AMD Other: Macuprev Group Other: Placebo Group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: monocentric, prospective, double blind randomized six months study
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)
Actual Study Start Date : January 18, 2018
Actual Primary Completion Date : October 19, 2018
Actual Study Completion Date : November 20, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Macuprev Group
patients taking oral supplementation (Macuprev) 2 capsules per day for 6 months
Other: Macuprev Group
oral supplementation (Macuprev) 2 capsules per day for 6 months

Placebo Comparator: Placebo Group
patients taking oral placebo 2 capsules per day for 6 months
Other: Placebo Group
oral placebo 2 capsules per day for 6 months




Primary Outcome Measures :
  1. Change of Multifocal electroretinogram (mfERG) in patients with dry age-related macular degeneration after 6 months follow up [ Time Frame: 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 :
  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 [ Time Frame: 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)



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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03919019


Locations
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Italy
Fondazione G.B.Bietti
Roma, Italy, 00135
Sponsors and Collaborators
Fondazione G.B. Bietti, IRCCS

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Mariacristina Parravano, Head Retina Unit, Fondazione G.B. Bietti, IRCCS
ClinicalTrials.gov Identifier: NCT03919019     History of Changes
Other Study ID Numbers: RET 04 2017
First Posted: April 18, 2019    Key Record Dates
Last Update Posted: May 9, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mariacristina Parravano, Fondazione G.B. Bietti, IRCCS:
oral supplementation
mfERG
OCT
Additional relevant MeSH terms:
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Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases