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Completed

NCT Number: NCT04778436

Macula Evolution in Patients With AMD Taking Oral Food Supplementation

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

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Key information

Conditions

Age Related Macular Degeneration Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wilfried Roquet

Clermont-Ferrand, 63000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Informed consent signed and dated
  • Age ≥ 50 years old
  • At least one Eligible Eye, defined by following conditions :
  • Far Best Corrected Visual Acuity (BCVA) ≥ 75 ETDRS letters (or ≥ 20/32 Snellen equivalent)
  • At least one drusen with a minimal diameter of 125 µM assessed by SD-OCT / intermediate age-related macular degeneration
  • Macula sparing
  • Clear ocular media
  • 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

Treatment and study plan

T7082

Dietary Supplement

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

Primary outcomes

  1. 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. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Laboratoires Thea

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 3, 2021
Registry last updated
Feb 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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