Macula Evolution in Patients With AMD Taking Oral Food Supplementation

Overview

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

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 24, 2022

Interventions

  • Dietary Supplement: T7082
    • Patients will take food supplementation for 12 months. For each patient : 5 visits with ophthalmogist and 6 phone call

Arms, Groups and Cohorts

  • Experimental: T7082
    • After inclusion, the patients will consume an association of 4 food supplements including Nutrof Total.

Clinical Trial Outcome Measures

Primary Measures

  • 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)
  • 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
  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 50 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Laboratoires Thea
  • Provider of Information About this Clinical Study
    • Sponsor

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