Stage 3 Age Related Macular Degeneration (AREDS Classification)PREVISIONNCT02395757
Microperimetry and Eye Progressing From Stage 3 to Stage 4 Age-related Macular Degeneration (AMD)
A study testing MAIA™ (Centervue, Padova, Italy; distributed in France by EDC Lamy, Carvin, France) in people with Stage 3 Age Related Macular Degeneration (AREDS Classification), run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Stage 3 Age Related Macular Degeneration (AREDS Classification)
- What is being tested?
- MAIA™ (Centervue, Padova, Italy; distributed in France by EDC Lamy, Carvin, France)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2015to 8 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Being tested
- MAIA™ (Centervue, Padova, Italy; distributed in France by EDC Lamy, Carvin, France)
- Keywords
- Age Related Macular Degeneration (AMD), Microperimetry, Diagnostic
- Medical subject headings
- Macular Degeneration, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MAIA™ (Centervue, Padova, Italy; distributed in France by EDC Lamy, Carvin, France)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.
| Study group | Role | What they receive |
|---|---|---|
| Microperimetry | Experimental | Microperimetry exam performed in addition to the usual ophthalmological examinations for monitoring AMD. Receives: Device: MAIA™ (Centervue, Padova, Italy; distributed in France by EDC Lamy, Carvin, France) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 24 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2015 (estimated)
- Study startSep 2015
- Primary completionSep 2017
- Study completion8 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stage 3 Age Related Macular Degeneration (AREDS Classification)Studies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02395757
- Sponsor's protocol ID
- 2014.862
- Acronym
- PREVISION
- Status last verified
- Oct 2016
- First submitted
- 20 Feb 2015
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 36120870
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment Using Microperimetry of the Risk of a Fellow Eye Progressing From Stage 3 to Stage 4 (AREDS Classification) Age-related Macular Degeneration (AMD)
- ClinicalTrials.gov ID
- NCT02395757
- Acronym / sponsor ID
- PREVISION / 2014.862
- Keywords
- Age Related Macular Degeneration (AMD), Microperimetry, Diagnostic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- Sep 2015 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- 8 Jan 2020 (actual)
- First posted
- 24 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Microperimetry | Experimental | Device: MAIA™ (Centervue, Padova, Italy; distributed in France by EDC Lamy, Carvin, France)Microperimetry exam performed in addition to the usual ophthalmological examinations for monitoring AMD. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Microperimetry |
Primary outcome
The sensitivity of the microperimetric parameter(s) and combination(s) of parameters according to patient status at final assessment.
Time frame: 24 months
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.
7 secondary outcomes
The specificity of the microperimetric parameter or combination of parameters with the highest level of sensitivity
Time frame: 24 months after inclusion
The positive predictive value of the microperimetric parameter or combination of parameters with the highest level of sensitivity
Time frame: 24 months after inclusion
The negative predictive value of the microperimetric parameter or combination of parameters with the highest level of sensitivity
Time frame: 24 months after inclusion
The sensitivity of the microperimetric parameters associated with the parameters from other ophthalmological examinations.
Time frame: 24 months after inclusion
The specificity of the microperimetric parameters associated with the parameters from other ophthalmological examinations.
Time frame: 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.
Time frame: 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.
Time frame: 24 months after inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Results publication: PubMed 36120870Kodjikian 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MAIA™ (Centervue, Padova, Italy; distributed in France by EDC Lamy, Carvin, France) in people with Stage 3 Age Related Macular Degeneration (AREDS Classification), run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The sensitivity of the microperimetric parameter(s) and combination(s) of parameters according to patient status at final assessment. (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02395757, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2025; AzTrials last refreshed its copy on 1 Nov 2026.