NCT01918553

Brief 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 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
516

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 8, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 7, 2013

Completed
1.9 years until next milestone

Study Start

First participant enrolled

July 9, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 23, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 23, 2017

Completed
Last Updated

April 29, 2020

Status Verified

April 1, 2020

Enrollment Period

1.6 years

First QC Date

July 8, 2013

Last Update Submit

April 28, 2020

Conditions

Elderly French PopulationAge-related Macular Degeneration

Keywords

AMDepidemiologyrisk factorscohort study

Outcome Measures

Primary Outcomes (1)

  • 8-year incidence of late AMD (neovascular and/or atrophic)

    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

    at day 0 (inclusion) and year 2 after inclusion (end of study)

Study Arms (1)

Subject in the study ALIENOR

EXPERIMENTAL
Other: clinical parametersOther: visual acuity examsOther: retinophotographyOther: SD-OCTOther: Intra ocular Pressure (IOP)Other: retinal imaging (OPTOMAP)Other: axial length (IOL master)

Interventions

clinical parametersOTHER
Subject in the study ALIENOR
visual acuity examsOTHER
Subject in the study ALIENOR
retinophotographyOTHER
Subject in the study ALIENOR
SD-OCTOTHER
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

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Subject participating in the study ALIENOR
  • Affiliated to a social security
  • Consent signed by the patient and the investigator

You may not qualify if:

  • \- Health incompatible with one hour and a half ophthalmic examination

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unité Médicale Rétine Neuro-Ophtalmologie - Service d'Ophtalmologie - Hopital Pellegrin

Bordeaux, 33000, France

Location

Related Publications (3)

  • 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.

    PMID: 23404120BACKGROUND

  • Merle 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.

    PMID: 21705687BACKGROUND

  • Delcourt 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.

    PMID: 21642625BACKGROUND

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Study Officials

  • Korobelnik Jean-François

    University Hospital Bordeaux, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2013

First Posted

August 7, 2013

Study Start

July 9, 2015

Primary Completion

February 23, 2017

Study Completion

February 23, 2017

Last Updated

April 29, 2020

Record last verified: 2020-04

Locations

FR(1)