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

NCT ID: NCT02395757

Last Updated: 2025-09-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 182 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2020-01-08

Brief 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)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Microperimetry

Microperimetry exam performed in addition to the usual ophthalmological examinations for monitoring AMD.

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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).

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis

INDUSTRY

Sponsor Role: collaborator

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospice Civils de Lyon

Lyon, , France

Countries

France

References

Kodjikian L, Creuzot-Garcher C, Korobelnik JF, Tadayoni R, Delafoy I, Leal C, Bernard L, Decullier E, Huot L, Mathis T. Microperimetry to predict disease progression in eyes at high risk of age-related macular degeneration disease: The PREVISION study. Acta Ophthalmol. 2023 Mar;101(2):e135-e142. doi: 10.1111/aos.15260. Epub 2022 Sep 19.

Reference Type: RESULT

PMID: 36120870 (View on PubMed)

Other Identifiers

2014.862

Identifier Type: -

Identifier Source: org_study_id