Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| T7082 | Experimental | After inclusion, the patients will consume an association of 4 food supplements including Nutrof Total. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| T7082 | Dietary Supplement | Patients will take food supplementation for 12 months. For each patient : 5 visits with ophthalmogist and 6 phone call |
|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Informed consent signed and dated
Age ≥ 50 years old
At least one Eligible Eye, defined by following conditions :
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wilfried Roquet | Clermont-Ferrand | 63000 | France |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
an open-label, single-arm, pilot study
Not provided
Not provided
Not provided
Not provided