Clinical and Genetic Analyzes of Age-related Macular Degeneration (COLDMLA)

May 12, 2023 updated by: Centre Hospitalier Intercommunal Creteil
The purpose of this collection is to search for susceptibility genes for age-related macular degeneration (AMD) alone or in combination with environmental factors and to look for genes that modulate the AMD phenotype (particularly the response to treatment).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

6000

Contacts and Locations

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

Study Contact

Study Locations

  • France
      • Bordeaux, France, 33000
      • Créteil, France, 94000
        • Recruiting
        • Chi Creteil
        • Contact:
          • Eric Soueid
      • Dijon, France, 21033
      • Paris, France, 75012
        • Recruiting
        • Hôpital des Quinze-Vingts
        • Contact:
      • Paris, France
        • Recruiting
        • Centre Ophtalmologique d'Imagerie et de Laser
        • Contact:
          • Cohen

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

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Diagnosis of exudative or atrophic AMD

Description

Inclusion Criteria:

  • Age> 55 years
  • Diagnosis of exudative or atrophic AMD in at least one eye
  • Patient informed of the objectives of the study and having freely signed the informed consent letter
  • Patient affiliated to a social security scheme

Exclusion Criteria:

  • Other retinal or choroidal lesion in the studied eye
  • History of severe systemic disease that could potentially hinder patient adherence to the study protocol: mental disorder, cancer, recent stroke or heart failure less than 3 months old.
  • Known allergy to fluorescein, indocyanine green, iodine or ranibizumab

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
AMD patient

During the AMD consultation, patients have their imaging exams including OCT, retinophotography, and fluorescein angiography.

After the interview with the doctor on pathology diagnosis and follow-up, they will meet the clinical research associate nurse to complete the questionnaire and perform anthropometric measurements (weight, height, abdominal perimeter measurement and blood pressure measurement). Patients recruited at Créteil will benefit from a venous blood sample (20 mL) in 2 EDTA tubes for DNA extraction after light reading and signature of consent. For patients recruited from other ophthalmic centers, the Clinical Research Associate will perform salivary sampling for DNA extraction after light reading and signature of consent.
Genetic: Sampling
Sampling
control without AMD

898/5000 Given the observation of a mutation in an unaffected control individual, it is not excluded that this individual may be suffering from AMD at a later age. The observation of the mutation could thus be considered as a pre-clinical test. None of the teams were able to obtain a control population of the same age and sex ratio, which could have benefited from fluorescein angiography or at least a fundus examination, to ensure the absence of warning signs of AMD. This requires cooperation from healthy elderly volunteers not only for blood sampling but also for pupillary dilatation.

The controls may be the accompanying persons or spouses of AMD patients. It may also be people seen in general consultation without maculopathy or retinopathy with an age greater than 55 years.
Genetic: Sampling
Sampling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Genotypic factors
Time Frame: 6 months
Identification of genotypic factors associated with good or poor response to treatment in precisely phenotyped AMD patients.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Predictive markers
Time Frame: 6 months
Look for predictive markers of cure response among polymorphisms that are susceptibility factors for AMD
6 months
Vascular Endothelial Growth Factor
Time Frame: 6 months
Look for predictors of treatment response among polymorphisms of other genes: Vascular Endothelial Growth Factor, Vascular Endothelial Growth Factor Receptor
6 months
Environmental factors
Time Frame: 6 months
Look for predictive markers of treatment response among environmental factors
6 months
Predictive treatment response score
Time Frame: 6 months
Create a predictive treatment response score that combines factors independently associated with the response to treatment in multivariate analysis
6 months
Circulating biological factors
Time Frame: 6 months
Identification of circulating biological factors such as circulating fatty acids at risk of AMD or modulating the response to treatment.
6 months

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Intercommunal Creteil

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)

November 1, 2005

Primary Completion (Anticipated)

November 1, 2024

Study Completion (Anticipated)

November 1, 2024

Study Registration Dates

First Submitted

July 30, 2018

First Submitted That Met QC Criteria

July 30, 2018

First Posted (Actual)

August 3, 2018

Study Record Updates

Last Update Posted (Actual)

May 15, 2023

Last Update Submitted That Met QC Criteria

May 12, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COLLECTION DMLA
  • 2013-A00110-45 (Other Identifier: ID-RCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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