Macula Evolution in Patients With AMD Taking Oral Food Supplementation

February 14, 2022 updated by: Laboratoires Thea

Macular Drusen Evolution in Patients With Intermediate Age-related Macular Degeneration (AMD) Taking Oral Food Supplementation: an Open-label,Single-arm Pilot Study

LT7082-001 is an open-label, single-arm pilot study. Patients with intermediate age-related macular degeneration (AMD) wil take T7082 during 12 months , an association of 4 food supplementations .

The study objectives are to describe morphological changes and evolution of drusen in macula after a 12-month of food supplementation and to assess the safety of T7082

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France, 63000
        • Wilfried Roquet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Informed consent signed and dated
  • Age ≥ 50 years old

  • At least one Eligible Eye, defined by following conditions :

    1. Far Best Corrected Visual Acuity (BCVA) ≥ 75 ETDRS letters (or ≥ 20/32 Snellen equivalent)
    2. At least one drusen with a minimal diameter of 125 µM assessed by SD-OCT / intermediate age-related macular degeneration
    3. Macula sparing
    4. Clear ocular media
    5. Adequate pupillary dilation

Exclusion Criteria:

  • Presence of other macular disease such as epiretinal membrane or macular telangiectasia.
  • Presence of any geographic atrophy including macular region
  • Any history of retina neovascularization
  • Macula or retinal diseases other than age-related macular degeneration
  • A concurrent ocular pathology that may contribute to vision loss (eg, choroidal neovascularization, glaucoma, visually significant cataract, optic neuropathy, history of retinal surgery) or interfere with acquisition of high-quality images
  • Ocular or periocular infections
  • Presence of congenital retinal pathologies that may impact data collection
  • Exudative AMD

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: T7082
After inclusion, the patients will consume an association of 4 food supplements including Nutrof Total.
Dietary supplement: T7082
Patients will take food supplementation for 12 months. For each patient : 5 visits with ophthalmogist and 6 phone call

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
evolution of drusen in the macula
Time Frame: 2 months, 5 months 8 months and 12 months
Change from baseline in drusen region in 4 categories (disappearance, decrease, stable, increase) at 2, 5 and 6 months by Optical Coherence Tomography (OCT-SD)
2 months, 5 months 8 months and 12 months
morphological changes in the macula
Time Frame: 2 months, 5 months 8 months and 12 months
Presence and/or evolution of atrophic area (Yes/No) at 2, 5, 6 and 12 months assessed by autofluorescence
2 months, 5 months 8 months and 12 months
Treatment-Emergent Adverse events (TEAE), Serious treatment-emergent adverse events (STEAE), Treatment-Emergent Adverse Reaction (TEAR)
Time Frame: 2 months, 5 months 8 months and 12 months
Frequency of TEAE,STEAE,TEAR
2 months, 5 months 8 months and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laboratoires Thea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 13, 2021

Primary Completion (ACTUAL)

January 24, 2022

Study Completion (ACTUAL)

January 24, 2022

Study Registration Dates

First Submitted

January 18, 2021

First Submitted That Met QC Criteria

February 26, 2021

First Posted (ACTUAL)

March 3, 2021

Study Record Updates

Last Update Posted (ACTUAL)

February 15, 2022

Last Update Submitted That Met QC Criteria

February 14, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LT7082-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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