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

Assessment Using Microperimetry of the Risk of a Fellow Eye Progressing From Stage 3 to Stage 4 (AREDS Classification) Age-related Macular Degeneration (AMD)

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.

Study Overview

• Status: Completed
• Conditions: Stage 3 Age Related Macular Degeneration (AREDS Classification)
• Intervention / Treatment: Device: MAIA™ (Centervue, Padova, Italy; distributed in France by EDC Lamy, Carvin, France)

• Study Type: Interventional
• Enrollment (Actual): 182
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69000
    • Hospice Civils de Lyon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Microperimetry; Microperimetry exam performed in addition to the usual ophthalmological examinations for monitoring AMD.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The sensitivity of the microperimetric parameter(s) and combination(s) of parameters according to patient status at final assessment.	The sensitivity of the microperimetry diagnostic tool will be measured by the ratio between the number of patients presenting both positive microperimetric parameters and advanced AMD (stage 4); and the total number of patients with advanced AMD diagnosed at final assessment.	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The specificity of the microperimetric parameter or combination of parameters with the highest level of sensitivity	The specificity of the microperimetry diagnostic tool will be measured by the ratio between the number of patients presenting both negative microperimetric parameters and no advanced AMD (stage 4); and the total number of patients with no advanced AMD diagnosed at final assessment.	24 months after inclusion
The positive predictive value of the microperimetric parameter or combination of parameters with the highest level of sensitivity	The positive predictive value of the microperimetry diagnostic tool will be measured by the ratio between the number of patients presenting both positive microperimetric parameters and advanced AMD (stage 4); and the total number of patients with positive microperimetric parameters.	24 months after inclusion
The negative predictive value of the microperimetric parameter or combination of parameters with the highest level of sensitivity	The negative predictive value of the microperimetry diagnostic tool will be measured by the ratio between the number of patients presenting both negative microperimetric parameters and no advanced AMD (stage 4); and the total number of patients with negative microperimetric parameters.	24 months after inclusion
The sensitivity of the microperimetric parameters associated with the parameters from other ophthalmological examinations.	The parameters of other ophthalmological examinations considered will be as follows: best corrected visual acuity measured according to ETDRS (number of letters) and Snellen scales; foveolar thickness, central 1-mm thickness, external limiting membrane (ELM) integrity, and ellipsoidal line integrity measured using SD-OCT (spectral domain optical coherence tomography). The sensitivity will be measured by the ratio between the number of patients presenting both positive parameters and advanced AMD (stage 4); and the total number of patients with advanced AMD diagnosed at final assessment.	24 months after inclusion
The specificity of the microperimetric parameters associated with the parameters from other ophthalmological examinations.	The parameters of other ophthalmological examinations considered will be as follows: best corrected visual acuity measured according to ETDRS (number of letters) and Snellen scales; foveolar thickness, central 1-mm thickness, external limiting membrane (ELM) integrity, and ellipsoidal line integrity measured using SD-OCT. The specificity will be measured by the ratio between the number of patients presenting both negative parameters and no advanced AMD (stage 4); and the total number of patients with no advanced AMD diagnosed at final assessment.	24 months after inclusion
The sensitivity of the microperimetric parameters or combinations of parameters for the sub-group of eyes presenting reticular pseudodrusen at inclusion.	The sensitivity will be measured by the ratio between the number of patients presenting both positive parameters and advanced AMD (stage 4); and the total number of patients with advanced AMD diagnosed at final assessment.	24 months after inclusion
The specificity of the microperimetric parameters or combinations of parameters for the sub-group of eyes presenting reticular pseudodrusen at inclusion.	The specificity will be measured by the ratio between the number of patients presenting both negative parameters and no advanced AMD (stage 4); and the total number of patients with no advanced AMD diagnosed at final assessment.	24 months after inclusion

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Collaborators: Novartis

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2015
• Primary Completion (Actual): September 1, 2017
• Study Completion (Actual): January 8, 2020

Study Registration Dates

• First Submitted: February 20, 2015
• First Submitted That Met QC Criteria: March 23, 2015
• First Posted (Estimate): March 24, 2015

Study Record Updates

• Last Update Posted (Actual): September 27, 2021
• Last Update Submitted That Met QC Criteria: September 21, 2021
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Diagnostic; Microperimetry; Age Related Macular Degeneration (AMD)
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration
• Other Study ID Numbers: 2014.862