Status:
COMPLETED
Macula Evolution in Patients With AMD Taking Oral Food Supplementation
Lead Sponsor:
Laboratoires Thea
Conditions:
Age Related Macular Degeneration
Eligibility:
All Genders
50+ years
Phase:
NA
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 . Th...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 13 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 24 2022
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04778436
Start Date
January 13 2021
End Date
January 24 2022
Last Update
February 15 2022
Active Locations (1)
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1
Wilfried Roquet
Clermont-Ferrand, France, 63000