Macula Evolution in Patients With AMD Taking Oral Food Supplementation

Age Related Macular Degeneration Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04778436
• Other study ID #: LT7082-001
• Status: Completed
• Phase: N/A
• Start date: January 13, 2021
• Est. completion date: January 24, 2022

Study information

• Verified date: February 2022
• Source: Laboratoires Thea
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: January 24, 2022
• Est. primary completion date: January 24, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Age Related Macular Degeneration
• Macular Degeneration

Intervention

Dietary Supplement:
• T7082
Patients will take food supplementation for 12 months. For each patient : 5 visits with ophthalmogist and 6 phone call

Locations

Country	Name	City	State
France	Wilfried Roquet	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
Laboratoires Thea

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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