Impact of Age-related Macular Degeneration on Daily Living Activitie (AMDAY)

Validation of Standardized Tasks and Questionnaires to Evaluate and Understand the Impact of Age-related Macular Degeneration on Daily Living Activitie

The complex and variable course of age-related diseases makes it all the more necessary to carry out personalised, reasoning-based examinations to improve the personalised assessment and management of AMD. However, functional assessment of AMD is most often based solely on visual acuity, and classifications of AMD are based solely on structural markers. There is therefore a need to improve the detection and functional assessment of this vision-threatening eye disease, by complementing and extending the standard assessments of clinical outcomes (COA)

Study Overview

• Status: Not yet recruiting
• Conditions: Age-Related Macular Degeneration
• Intervention / Treatment: Other: patient-reported outcome

Detailed Description

Prospective, longitudinal, interventional, exploratory, non-randomised, single-centre study, including healthy volunteers and patients with Age-Related Macular Degeneration

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nabil BROUK; Phone Number: +33140021738; Email: nbrouk@15-20.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• General criteria for healthy volunteers and AMD patients:

  • Male / Female participant,
  • Age ≥ 50 at inclusion,
  • Able and willing to provide written informed consent and comply with the study protocol, visits and assessments,
  • Quality of AO imaging as assessed by rtx1 camera, ● deemed adequate according to the study physician,
  • Membership of a social security scheme or beneficiary of such a scheme.

• Specific criteria for the AMD group:

  • Geriatric Depression Scale (GDS) questionnaire score ≤ 10 A COGEVIS questionnaire score ≥ 24/30
  • Visual acuity greater than 4/10ths

• General criteria for healthy volunteers:

  • No detectable visual pathologies
  • Best monocular visual acuity (corrected to 100% of the contrast) ≥ 8/10ths before age 70 and ≥ 6/10ths after.
  • MMSE score ≥ 20

• Specific criteria for the group of healthy volunteers with central microdrusens:

  • No detectable visual pathologies other than the presence of central microdrusens.
  • Best monocular visual acuity (corrected to 100% contrast) ≥ 8/10th before age 70 and ≥ 6/10th after.
  • MMSE score ≥ 20

Exclusion Criteria:

• Pregnant, parturient or breast-feeding women,
• Subjects taking medication likely to cause motor, visual, vestibular or cognitive disorders (PSA, neuroleptics, etc.) or who could interfere with the study examinations cannot be included in this study,
• Environmental opacity or eye movement disorders (nystagmus) which, in the opinion of the investigator, interfere with the quality of retinal imaging data.
• Any concomitant intraocular condition in the study eye (e.g. glaucoma or cataract) that, in the opinion of the investigator, would require surgical intervention during the study to prevent or treat vision loss that may result from this condition or affect the interpretation of study results,
• Known systemic disease which, in the opinion of the investigator, would preclude active participation in the study,
• Participation in any other therapeutic study evaluating a drug,
• Cognitively impaired subjects, illiterate subjects and subjects who do not speak the national language.
• Subjects with dyslexic reading disorders,
• Subjects subject to a reinforced protection measure or legal safeguard (curatorship, guardianship).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Patients with early-stage AMD; 30Patients with early-stage AMD	Other: patient-reported outcome; Performance of real-life tests and tasks
Other: Patients with intermediate-stage AMD; 30 with intermediate-stage AMD	Other: patient-reported outcome; Performance of real-life tests and tasks
Other: 30 healthy volunteers; Without AMD risk	Other: patient-reported outcome; Performance of real-life tests and tasks
Other: 30 healthy volunteers with central microdrusens (at risk of developing AMD); with central microdrusens (at risk of developing AMD)	Other: patient-reported outcome; Performance of real-life tests and tasks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Validity of criteria	Number of patients with capacity of discrimintaion compared to healthy volunteers. ROC (receiver operating characteristic curve), which illustrates the diagnostic capacity of a binary classification system as a function of the variation in its discrimination threshold. The ROC curve is created by plotting the rate of true positives versus the false-positive rate for different thresholds. The index used to characterize a test's of a test is the air under the curve	26 month
Validity of content	number of paticipants with capacity to execute questionnaires and daily real-life task	26 month
Reproducibility of results	Number of patients able to reproduce the same performance tests	26 month

Collaborators and Investigators

• Sponsor: Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
• Investigators: Principal Investigator: Michel PAQUES, Pr, centre Hospitalier Nationald'Ophtalmologie

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2029

Study Registration Dates

• First Submitted: January 26, 2024
• First Submitted That Met QC Criteria: March 20, 2024
• First Posted (Actual): March 27, 2024

Study Record Updates

• Last Update Posted (Actual): March 27, 2024
• Last Update Submitted That Met QC Criteria: March 20, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration
• Other Study ID Numbers: P22-09

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No