MacuTest Website for Personalized AMD Risk Prediction and Prevention

NCT05675917 | Withdrawn

• 1 other identifier: CHUBX 2022/46
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

LEHA team of Bordeaux University has developed an Age-related Macular Degeneration (AMD) prediction algorithm (taking into account age, 49 genetic variants, the presence of early retinal abnormalities, tobacco consumption, food quality, blood pressure and education level) and is currently developing the MacuTest website, integrating this prediction algorithm. This platform offers participants the possibility to enter their personal lifestyle data, to couple them with an ophthalmological examination and a genetic test, in order to evaluate their personalized risk of AMD. The main objective of this pilot study is to evaluate the feasibility of estimating the predicted AMD risk

Conditions

Macular Degeneration

Keywords

Macular degeneration; prediction; digital platform; personalized medicine

Outcome Measures

Primary Outcomes (1)

• estimation of AMD risk

  Percentage of participants who received an estimation of their risk of AMD

  Month 6

Secondary Outcomes (4)

• Socio-demographic characteristics

  baseline

• Lifestyle characteristics

  baseline

• Ophthalmological characteristics

  baseline

• Genetic risk

  baseline

Study Arms (1)

MacuTest website

EXPERIMENTAL

The MacuTest platform will be used to collect the data needed to predict AMD risk. AMD risk prediction is evaluated by a mathematical algorithm based on the data collected and integrated into the platform. The ophthalmologist will fill in the ophthalmologist questionnaire in the platform with data on the fundus and blood pressure, after examining the patient. The patient will fill in the lifestyle questionnaires (nutrition, smoking, gender, year of birth, level of education) with his personal equipment (computer, smartphone or tablet).

Device: MacuTest platform

Interventions

MacuTest platform DEVICE

The MacuTest platform will be used to collect the data needed to predict AMD risk. AMD risk prediction is evaluated by a mathematical algorithm based on the data collected and integrated into the platform. The ophthalmologist will fill in the ophthalmologist questionnaire in the platform with data on the fundus and blood pressure, after examining the patient. The patient will fill in the lifestyle questionnaires (nutrition, smoking, gender, year of birth, level of education) with his personal equipment (computer, smartphone or tablet).

MacuTest website

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Patients aged 65 years and older of European geographic origin
• Presence of early signs of AMD (drusen and/or pigment abnormalities) and/or parents with advanced AMD.
• Absence of any advanced form of AMD (atrophic or neovascular AMD).
• Patient who can read, understand and speak French.
• Patient with access to the MacuTest internet platform throughout the study (telephone, tablet, computer).
• Patient with the ability and willingness to carry out all planned visits and assessments.
• Patient with health insurance.
• Signed informed consent.

You may not qualify if:

• Presence of a severe ocular pathology that prevents an examination of the fundus.
• Patient with a history of a medical condition that, in the opinion of the investigator, would prevent the completion of scheduled study visits and completion of the study.
• Adult under legal protection or residing in a health or social institution.

Sponsors & Collaborators

• University Hospital, Bordeaux: lead
• University of Bordeaux: collaborator

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: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2022
• First Posted: January 9, 2023
• Study Start: February 2, 2024
• Primary Completion: February 2, 2024
• Study Completion: February 2, 2024
• Last Updated: February 12, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share