Macula Evolution in Patients With AMD Taking Oral Food Supplementation

Thea Pharma

Status: Completed

Conditions: Age Related Macular Degeneration

Treatments: Dietary Supplement: T7082

Study type: Interventional

Funder types: Industry

Identifiers

NCT04778436

LT7082-001

Details and patient eligibility

About

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

Enrollment: 10 patients

Sex: All

Ages: 50+ years old

Volunteers: No 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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

T7082

Experimental group

Description:

After inclusion, the patients will consume an association of 4 food supplements including Nutrof Total.

Treatment:

Dietary Supplement: T7082