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Microperimetry and Eye Progressing From Stage 3 to Stage 4 Age-related Macular Degeneration (AMD)

NCT02395757 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 182

Last updated 2025-09-12

No results posted yet for this study

Summary

Age-related macular degeneration (AMD) is an acquired retinal pathology affecting the central region of the retina responsible for discrimination between high spatial frequencies (reading), colour vision and the central visual field. The loss of visual acuity which occurs with the onset of AMD significantly affects patients' quality of life. In developed countries, AMD is the leading cause of vision impairment for people aged over 50 years. Its prevalence in Europe in people aged over 65 years is 3.3%. In France, around 2 million people suffer from this disease.

In the first stage of the disease it is known as age-related maculopathy (ARM). This early form of the disease can develop into intermediate AMD (stage 3 of the AREDS classification) and then advanced AMD (stage 4 AREDS), which can be atrophic or exudative. In cases of exudative AMD, the intravitreal administration of anti-VEGF drugs can limit the disease's progression.

It is therefore vital to adopt a strategy to assess the stage of the disease and provide the appropriate care management at the earliest possible stage. This is even more important for patients with advanced AMD in one eye and intermediate AMD in the fellow eye, as the risk of the fellow eye progressing to the advanced stage within 5 years is between 35% and 53%.

Microperimetry is a promising new diagnostic method which combines measurements of light sensitivity, loss of fixation and the anatomy of the retina. It offers a new approach to the functional assessment of retinal damage in patients with AMD, as it precisely correlates anatomical and functional modifications by measuring the loss of sensitivity and macular fixation. It has been shown that the more advanced the patient's AMD is, the further the parameters measured by microperimetry are from the norm.

The investigators want to assess the MAIA™ as a means of screening for AMD progression in patients with a high risk of progressing to a more advanced stage (patients presenting one eye with advanced AMD and a fellow eye with stage 3 AMD according to the AREDS classification). The research hypothesis for our proposed study is that the parameters measured using microperimetry will already show abnormal results in the study eye prior to progressing to a more advanced stage of the disease. The use of these microperimetric parameters as predictor of progression would therefore make it possible to screen eyes likely to develop from intermediate to advanced AMD at an earlier stage, and subsequently provide patients who need it with earlier follow-up, preventive treatment or adapted, personalized rehabilitation as appropriate.

Conditions

  • Stage 3 Age Related Macular Degeneration (AREDS Classification)

Interventions

DEVICE

MAIA™ (Centervue, Padova, Italy; distributed in France by EDC Lamy, Carvin, France)

An automatic microperimetry exam of the 10° central macular coverage "expert test" (customized grid) will be performed with the MAIA™ device at each semi-annual follow-up visit.

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • Hospices Civils de Lyon

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2017-09-30
Completion
2020-01-08

Countries

  • France

Study Locations

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Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02395757 on ClinicalTrials.gov