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Macula Evolution in Patients With AMD Taking Oral Food Supplementation

Primary Purpose

Age Related Macular Degeneration

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

T7082

About this trial

This is an interventional other trial for Age Related Macular Degeneration

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Wilfried Roquet

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

T7082

Arm Description

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

Outcomes

Primary Outcome Measures

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)

morphological changes in the macula

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)

Frequency of TEAE,STEAE,TEAR

Secondary Outcome Measures

Full Information

NCT ID

NCT04778436

First Posted

January 18, 2021

Last Updated

February 14, 2022

Sponsor

Laboratoires Thea

1. Study Identification

Unique Protocol Identification Number

NCT04778436

Brief Title

Macula Evolution in Patients With AMD Taking Oral Food Supplementation

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Completed

Study Start Date

January 13, 2021 (Actual)

Primary Completion Date

January 24, 2022 (Actual)

Study Completion Date

January 24, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Laboratoires Thea

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Age Related Macular Degeneration

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

an open-label, single-arm, pilot study

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

T7082

Arm Type

Experimental

Arm Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

T7082

Intervention Description

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

Primary Outcome Measure Information:

Title

evolution of drusen in the macula

Description

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

Title

morphological changes in the macula

Description

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

Title

Treatment-Emergent Adverse events (TEAE), Serious treatment-emergent adverse events (STEAE), Treatment-Emergent Adverse Reaction (TEAR)

Description

Frequency of TEAE,STEAE,TEAR

Time Frame

2 months, 5 months 8 months and 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Wilfried Roquet

City

Clermont-Ferrand

ZIP/Postal Code

63000

Country

France

12. IPD Sharing Statement

Plan to Share IPD

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Macula Evolution in Patients With AMD Taking Oral Food Supplementation

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