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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
10
Patients will take food supplementation for 12 months. For each patient : 5 visits with ophthalmogist and 6 phone call
Wilfried Roquet
Clermont-Ferrand, France
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)
Time frame: 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
Time frame: 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
Time frame: 2 months, 5 months 8 months and 12 months
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