Cohort Study on the Age-related Macular Degeneration: Incidence and Research for Predisposing Factors (ECLAIR)

April 28, 2020 updated by: University Hospital, Bordeaux
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

516

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France, 33000
        • Unité Médicale Rétine Neuro-Ophtalmologie - Service d'Ophtalmologie - Hopital Pellegrin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

- Health incompatible with one hour and a half ophthalmic examination

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Subject in the study ALIENOR
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
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 Outcome Measures

Outcome Measure
Time Frame
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)
at day 0 (inclusion) and year 2 after inclusion (end of study)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

Investigators

  • Principal Investigator: Korobelnik Jean-François, University Hospital Bordeaux, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 9, 2015

Primary Completion (Actual)

February 23, 2017

Study Completion (Actual)

February 23, 2017

Study Registration Dates

First Submitted

July 8, 2013

First Submitted That Met QC Criteria

August 5, 2013

First Posted (Estimate)

August 7, 2013

Study Record Updates

Last Update Posted (Actual)

April 29, 2020

Last Update Submitted That Met QC Criteria

April 28, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX 2012/31

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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