Macula Evolution in Patients With AMD Taking Oral Food Supplementation

NCT04778436 | Completed

• 1 other identifier: LT7082-001
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Conditions

Age Related Macular Degeneration

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

T7082

EXPERIMENTAL

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

Dietary Supplement: T7082

Interventions

T7082 DIETARY_SUPPLEMENT

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

T7082

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Laboratoires Thea: lead

Study Sites (1)

Wilfried Roquet

Clermont-Ferrand, 63000, France

Location

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: an open-label, single-arm, pilot study

Study Record Dates

• First Submitted: January 18, 2021
• First Posted: March 3, 2021
• Study Start: January 13, 2021
• Primary Completion: January 24, 2022
• Study Completion: January 24, 2022
• Last Updated: February 15, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)