Macula Evolution in Patients With AMD Taking Oral Food Supplementation

Sponsor

Laboratoires Thea (Industry)

Overall Status

Completed

CT.gov ID

NCT04778436

Collaborator

(none)

Enrollment

Location

Arm

12.4

Actual Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Age Related Macular Degeneration	Dietary Supplement: T7082	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

an open-label, single-arm, pilot studyan open-label, single-arm, pilot study

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Macular Drusen Evolution in Patients With Intermediate Age-related Macular Degeneration (AMD) Taking Oral Food Supplementation: an Open-label,Single-arm Pilot Study

Actual Study Start Date :

Jan 13, 2021

Actual Primary Completion Date :

Jan 24, 2022

Actual Study Completion Date :

Jan 24, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: T7082 After inclusion, the patients will consume an association of 4 food supplements including Nutrof Total.	Dietary Supplement: T7082 Patients will take food supplementation for 12 months. For each patient : 5 visits with ophthalmogist and 6 phone call

Arm

Intervention/Treatment

Experimental: T7082

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

Dietary Supplement: T7082

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

Outcome Measures

Primary Outcome Measures

evolution of drusen in the macula [2 months, 5 months 8 months and 12 months]
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)
morphological changes in the macula [2 months, 5 months 8 months and 12 months]
Presence and/or evolution of atrophic area (Yes/No) at 2, 5, 6 and 12 months assessed by autofluorescence
Treatment-Emergent Adverse events (TEAE), Serious treatment-emergent adverse events (STEAE), Treatment-Emergent Adverse Reaction (TEAR) [2 months, 5 months 8 months and 12 months]
Frequency of TEAE,STEAE,TEAR

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Wilfried Roquet	Clermont-Ferrand		France	63000

Sponsors and Collaborators

Laboratoires Thea

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Laboratoires Thea

ClinicalTrials.gov Identifier:

NCT04778436

Other Study ID Numbers:

LT7082-001

First Posted:

Mar 3, 2021

Last Update Posted:

Feb 15, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Macular Degeneration

Study Results

No Results Posted as of Feb 15, 2022