Macula Evolution in Patients With AMD Taking Oral Food Supplementation

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04778436

Enrollment

Registered

2021-03-03

Start date

2021-01-13

Completion date

2022-01-24

Last updated

2022-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Age Related Macular Degeneration

Brief summary

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

Interventions

DIETARY_SUPPLEMENTT7082

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Intervention model description

an open-label, single-arm, pilot study

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026