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

Civil Hospices of Lyon

Status

Completed

Conditions

Stage 3 Age Related Macular Degeneration (AREDS Classification)

Treatments

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

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02395757

2014.862

Details and patient eligibility

About

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.

Enrollment

182 patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patient aged 50 years or over;
Patient who has given their free, informed, signed consent;
Patient with a French social security number or equivalent cover;
Patient presenting one eye with stage 4 AMD (according to the AREDS classification), and drusen in the fellow eye (study eye) with at least one drusen with a diameter of over 125 microns and/or extra- foveal atrophy (stage 3 AREDS);
Patient who is willing and able to attend all the clinical appointments required for the study and complete all the related procedures.

Exclusion criteria

Patient aged under 50 years;
Patient who refuses to take part in the study;
Woman who is pregnant or breastfeeding;
Protected adult as set out in French law (French Public Health Law);
Patient presenting a study eye with stage 1, 2 or 4 AMD (AREDS classification);
Patient presenting another maculopathy in the study eye;
Area alteration (cornea, lens, vitreous humour) which makes it impossible to carry out and interpret the microperimetry correctly;
Patient due to undergo cataract surgery in the study eye during the 2-year study period;
Patients who cannot be followed up for the full 2 years;
Patients participating simultaneously in other studies which may interfere with the study results (in either eye).