Elderly French PopulationECLAIRNCT01918553
Cohort Study on the Age-related Macular Degeneration: Incidence and Research for Predisposing Factors
A study testing clinical parameters, visual acuity exams and retinophotography in people with Elderly French Population and Age-related Macular Degeneration, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
Age-related Macular Degeneration (AMD) is the most cause of blindness in the industrialised countries. There are few epidemiological studies on the incidence of this disease. Studying the incidence of AMD in an elderly French population and identifying the predisposing factors is very important to allow a major… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Elderly French Population, Age-related Macular Degeneration
- What is being tested?
- clinical parameters, visual acuity exams and retinophotography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 516 participants
- Where
- 1 siteFrance
- Study dates
- 9 Jul 2015to 23 Feb 2017
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Subject participating in the study ALIENOR
- Affiliated to a social security
- Consent signed by the patient and the investigator
Who cannot join
- Health incompatible with one hour and a half ophthalmic examination
Trial locations and contacts
1 site in 1 country.
France1 site
Unité Médicale Rétine Neuro-Ophtalmologie - Service d'Ophtalmologie - Hopital Pellegrin
Bordeaux, 33000
About this study
Age-related Macular Degeneration (AMD) is the most cause of blindness in the industrialised countries. There are few epidemiological studies on the incidence of this disease. Studying the incidence of AMD in an elderly French population and identifying the predisposing factors is very important to allow a major advance in the epidemiological knowledge of AMD. This study will contribute to the identification of the clinical, genetic and modifiable parameters associated at the risk of developing AMD. This could result in means prevention as well as in the identification of subjects as high risk of AMD
Read the detailed description
Age-related Macular Degeneration is the most cause of blindness in the industrialised countries. There are few French epidemiological data on this disease. Worldwide, studies have included a small number of very old subjects. Thus, it is important to estimate the AMD incidence in an elderly French population, in order to evaluate more precisely the number of cases in the French population. Besides, some clinical, genetic and modifiable parameters predisposing to the AMD are under study. The aim of the ECLAIR project is to study the 8-year incidence of AMD in an elderly French population and to identify the predisposing factors. It is based on an existing cohort study (ALIENOR) in which some clinical, genetic and modifiable data were collected at baseline, 2 and 4 years. It is the only cohort study performed in France in this field since fifteen years in parallel with another one performed in Dijon according to the same methodology. It is important to extend the study to 8 years in order to have a sufficient statistical power for the identification of predisposing factors. In the ECLAIR study, there is no treatment. The subjects will be followed during 2 years (6 and 8 years after baseline of the Alienor study). The visit 1 (A0) will be the inclusion visit where the subjects will sign the inform consent and will perform ophthalmological examinations. The subjects will come back 2 years later for the visit 2 (A2). In this second visit, the ophthalmological examinations will be the same that is: measure of clinical parameters, measurement of visual acuity exams, retinophotography,spectral domain optical coherence tomography (SD-OCT), intraocular pressure, retinal imaging (OPTOMAP), axial length (IOL master)
- Being tested
- clinical parameters, visual acuity exams, retinophotography, SD-OCT, Intra ocular Pressure (IOP)
- Keywords
- AMD, epidemiology, risk factors, cohort study
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clinical parametersOther
visual acuity examsOther
retinophotographyOther
SD-OCTOther
Intra ocular Pressure (IOP)Other
retinal imaging (OPTOMAP)Other
axial length (IOL master)Other
| Study group | Role | What they receive |
|---|---|---|
| Subject in the study ALIENOR | Experimental | Not described Receives: Other: clinical parameters; Other: visual acuity exams; Other: retinophotography; Other: SD-OCT; Other: Intra ocular Pressure (IOP); Other: retinal imaging (OPTOMAP); Other: axial length (IOL master) |
What is being measured
The primary outcome is the main question the study is designed to answer.
8-year incidence of late AMD (neovascular and/or atrophic)
Measured: at day 0 (inclusion in ECLAIR study and 6 years after inclusion in ALIENOR cohort) and year 2 after inclusion (end of ECLAIR study and 8 years after inclusion in ALIENOR cohort)
Secondary outcomes (1)
best-corrected visual acuity (ETDRS methodology) measured in visit 1 and 2 years later with ETDRS methodology
Measured: at day 0 (inclusion) and year 2 after inclusion (end of study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2013 (estimated)
- Study start9 Jul 2015
- Primary completion23 Feb 2017
- Study completion23 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Elderly French PopulationStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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
- 516 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Korobelnik Jean-François, Principal investigator, University Hospital Bordeaux, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01918553
- Sponsor's protocol ID
- CHUBX 2012/31
- Other IDs
- 2013-A00366-39
- Acronym
- ECLAIR
- Status last verified
- Apr 2020
- First submitted
- 8 Jul 2013
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Cougnard-Gregoire A, Delyfer MN, Korobelnik JF, Rougier MB, Malet F, Le Goff M, Dartigues JF, Colin J, Barberger-Gateau P, Delcourt C. Long-term blood pressure and age-related macular degeneration: the ALIENOR study. Invest Ophthalmol Vis Sci. 2013 Mar 28;54(3):1905-12. doi: 10.1167/iovs.12-10192.
PubMed 23404120Merle B, Delyfer MN, Korobelnik JF, Rougier MB, Colin J, Malet F, Feart C, Le Goff M, Dartigues JF, Barberger-Gateau P, Delcourt C. Dietary omega-3 fatty acids and the risk for age-related maculopathy: the Alienor Study. Invest Ophthalmol Vis Sci. 2011 Jul 29;52(8):6004-11. doi: 10.1167/iovs.11-7254.
PubMed 21705687Delcourt C, Delyfer MN, Rougier MB, Amouyel P, Colin J, Le Goff M, Malet F, Dartigues JF, Lambert JC, Korobelnik JF. Associations of complement factor H and smoking with early age-related macular degeneration: the ALIENOR study. Invest Ophthalmol Vis Sci. 2011 Jul 29;52(8):5955-62. doi: 10.1167/iovs.10-6235.
PubMed 21642625Schweitzer C, Korobelnik JF, Boniol M, Cougnard-Gregoire A, Le Goff M, Malet F, Rougier MB, Delyfer MN, Dartigues JF, Delcourt C. Associations of Biomechanical Properties of the Cornea With Environmental and Metabolic Factors in an Elderly Population: The ALIENOR Study. Invest Ophthalmol Vis Sci. 2016 Apr 1;57(4):2003-11. doi: 10.1167/iovs.16-19226.
PubMed 27100157Chan H, Cougnard-Gregoire A, Delyfer MN, Combillet F, Rougier MB, Schweitzer C, Dartigues JF, Korobelnik JF, Delcourt C. Multimodal Imaging of Reticular Pseudodrusen in a Population-Based Setting: The Alienor Study. Invest Ophthalmol Vis Sci. 2016 Jun 1;57(7):3058-65. doi: 10.1167/iovs.16-19487.
PubMed 27367498Cougnard-Gregoire A, Merle BM, Korobelnik JF, Rougier MB, Delyfer MN, Le Goff M, Samieri C, Dartigues JF, Delcourt C. Olive Oil Consumption and Age-Related Macular Degeneration: The Alienor Study. PLoS One. 2016 Jul 28;11(7):e0160240. doi: 10.1371/journal.pone.0160240. eCollection 2016.
PubMed 27467382Schweitzer C, Korobelnik JF, Le Goff M, Rahimian O, Malet F, Rougier MB, Delyfer MN, Dartigues JF, Delcourt C. Diagnostic Performance of Peripapillary Retinal Nerve Fiber Layer Thickness for Detection of Glaucoma in an Elderly Population: The ALIENOR Study. Invest Ophthalmol Vis Sci. 2016 Nov 1;57(14):5882-5891. doi: 10.1167/iovs.16-20104.
PubMed 27802518
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort Study on the Age-related Macular Degeneration: Incidence and Research for Predisposing Factors
- ClinicalTrials.gov ID
- NCT01918553
- Acronym / sponsor ID
- ECLAIR / CHUBX 2012/31
- Keywords
- AMD, epidemiology, risk factors, cohort study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 516 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 9 Jul 2015 (actual)
- Primary completion
- 23 Feb 2017 (actual)
- Study completion
- 23 Feb 2017 (actual)
- First posted
- 7 Aug 2013 (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 the most cause of blindness in the industrialised countries. There are few epidemiological studies on the incidence of this disease. Studying the incidence of AMD in an elderly French population and identifying the predisposing factors is very important to allow a major advance in the epidemiological knowledge of AMD. This study will contribute to the identification of the clinical, genetic and modifiable parameters associated at the risk of developing AMD. This could result in means prevention as well as in the identification of subjects as high risk of AMD
Detailed description
Age-related Macular Degeneration is the most cause of blindness in the industrialised countries. There are few French epidemiological data on this disease. Worldwide, studies have included a small number of very old subjects. Thus, it is important to estimate the AMD incidence in an elderly French population, in order to evaluate more precisely the number of cases in the French population. Besides, some clinical, genetic and modifiable parameters predisposing to the AMD are under study. The aim of the ECLAIR project is to study the 8-year incidence of AMD in an elderly French population and to identify the predisposing factors. It is based on an existing cohort study (ALIENOR) in which some clinical, genetic and modifiable data were collected at baseline, 2 and 4 years. It is the only cohort study performed in France in this field since fifteen years in parallel with another one performed in Dijon according to the same methodology. It is important to extend the study to 8 years in order to have a sufficient statistical power for the identification of predisposing factors. In the ECLAIR study, there is no treatment. The subjects will be followed during 2 years (6 and 8 years after baseline of the Alienor study). The visit 1 (A0) will be the inclusion visit where the subjects will sign the inform consent and will perform ophthalmological examinations. The subjects will come back 2 years later for the visit 2 (A2). In this second visit, the ophthalmological examinations will be the same that is: measure of clinical parameters, measurement of visual acuity exams, retinophotography,spectral domain optical coherence tomography (SD-OCT), intraocular pressure, retinal imaging (OPTOMAP), axial length (IOL master)
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subject in the study ALIENOR | Experimental | Other: clinical parameters, Other: visual acuity exams, Other: retinophotography, Other: SD-OCT, Other: Intra ocular Pressure (IOP), Other: retinal imaging (OPTOMAP), Other: axial length (IOL master) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Subject participating in the study ALIENOR
- Affiliated to a social security
- Consent signed by the patient and the investigator
Key exclusion criteria (1 listed)
- Health incompatible with one hour and a half ophthalmic examination
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 |
|---|---|---|
| clinical parameters | Other | Subject in the study ALIENOR |
| visual acuity exams | Other | Subject in the study ALIENOR |
| retinophotography | Other | Subject in the study ALIENOR |
| SD-OCT | Other | Subject in the study ALIENOR |
| Intra ocular Pressure (IOP) | Other | Subject in the study ALIENOR |
| retinal imaging (OPTOMAP) | Other | Subject in the study ALIENOR |
| axial length (IOL master) | Other | Subject in the study ALIENOR |
Primary outcome
8-year incidence of late AMD (neovascular and/or atrophic)
Time frame: at day 0 (inclusion in ECLAIR study and 6 years after inclusion in ALIENOR cohort) and year 2 after inclusion (end of ECLAIR study and 8 years after inclusion in ALIENOR cohort)
1 secondary outcome
best-corrected visual acuity (ETDRS methodology) measured in visit 1 and 2 years later with ETDRS methodology
Time frame: at day 0 (inclusion) and year 2 after inclusion (end of study)
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 14 May 2026.
- Background: PubMed 23404120Cougnard-Gregoire A, Delyfer MN, Korobelnik JF, Rougier MB, Malet F, Le Goff M, Dartigues JF, Colin J, Barberger-Gateau P, Delcourt C. Long-term blood pressure and age-related macular degeneration: the ALIENOR study. Invest Ophthalmol Vis Sci. 2013 Mar 28;54(3):1905-12. doi: 10.1167/iovs.12-10192.
- Background: PubMed 21705687Merle B, Delyfer MN, Korobelnik JF, Rougier MB, Colin J, Malet F, Feart C, Le Goff M, Dartigues JF, Barberger-Gateau P, Delcourt C. Dietary omega-3 fatty acids and the risk for age-related maculopathy: the Alienor Study. Invest Ophthalmol Vis Sci. 2011 Jul 29;52(8):6004-11. doi: 10.1167/iovs.11-7254.
- Background: PubMed 21642625Delcourt C, Delyfer MN, Rougier MB, Amouyel P, Colin J, Le Goff M, Malet F, Dartigues JF, Lambert JC, Korobelnik JF. Associations of complement factor H and smoking with early age-related macular degeneration: the ALIENOR study. Invest Ophthalmol Vis Sci. 2011 Jul 29;52(8):5955-62. doi: 10.1167/iovs.10-6235.
- Results publication: PubMed 27100157Schweitzer C, Korobelnik JF, Boniol M, Cougnard-Gregoire A, Le Goff M, Malet F, Rougier MB, Delyfer MN, Dartigues JF, Delcourt C. Associations of Biomechanical Properties of the Cornea With Environmental and Metabolic Factors in an Elderly Population: The ALIENOR Study. Invest Ophthalmol Vis Sci. 2016 Apr 1;57(4):2003-11. doi: 10.1167/iovs.16-19226.
- Results publication: PubMed 27367498Chan H, Cougnard-Gregoire A, Delyfer MN, Combillet F, Rougier MB, Schweitzer C, Dartigues JF, Korobelnik JF, Delcourt C. Multimodal Imaging of Reticular Pseudodrusen in a Population-Based Setting: The Alienor Study. Invest Ophthalmol Vis Sci. 2016 Jun 1;57(7):3058-65. doi: 10.1167/iovs.16-19487.
- Results publication: PubMed 27467382Cougnard-Gregoire A, Merle BM, Korobelnik JF, Rougier MB, Delyfer MN, Le Goff M, Samieri C, Dartigues JF, Delcourt C. Olive Oil Consumption and Age-Related Macular Degeneration: The Alienor Study. PLoS One. 2016 Jul 28;11(7):e0160240. doi: 10.1371/journal.pone.0160240. eCollection 2016.
- Results publication: PubMed 27802518Schweitzer C, Korobelnik JF, Le Goff M, Rahimian O, Malet F, Rougier MB, Delyfer MN, Dartigues JF, Delcourt C. Diagnostic Performance of Peripapillary Retinal Nerve Fiber Layer Thickness for Detection of Glaucoma in an Elderly Population: The ALIENOR Study. Invest Ophthalmol Vis Sci. 2016 Nov 1;57(14):5882-5891. doi: 10.1167/iovs.16-20104.
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.
Korobelnik Jean-François principal investigator
University Hospital Bordeaux, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing clinical parameters, visual acuity exams and retinophotography in people with Elderly French Population and Age-related Macular Degeneration, run by University Hospital, Bordeaux 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 3 inclusion and 1 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 14 May 2026. 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?
8-year incidence of late AMD (neovascular and/or atrophic) (time frame: at day 0 (inclusion in ECLAIR study and 6 years after inclusion in ALIENOR cohort) and year 2 after inclusion (end of ECLAIR study and 8 years after inclusion in ALIENOR cohort)). 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 NCT01918553, which also lists 7 linked publications.
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 14 May 2026.