Macula Evolution in Patients With AMD Taking Oral Food Supplementation

Study Overview
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Brief Summary
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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

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

Conditions
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Age Related Macular Degeneration

Intervention / Treatment
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* Dietary Supplement: T7082


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: an open-label, single-arm, pilot study
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evolution of drusen in the macula | 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 | 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) | Frequency of TEAE,STEAE,TEAR | 2 months, 5 months 8 months and 12 months |