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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03614481
Recruitment Status : Recruiting
First Posted : August 3, 2018
Last Update Posted : August 4, 2020
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Intercommunal Creteil

Brief Summary:
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).

Condition or disease Intervention/treatment
Macular Degeneration Genetic: Sampling

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Study Type : Observational
Estimated Enrollment : 6000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical and Genetic Analyzes of Age-related Macular Degeneration
Actual Study Start Date : November 2005
Estimated Primary Completion Date : November 2022
Estimated Study Completion Date : November 2022

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Genotypic factors [ Time Frame: 6 months ]
    Identification of genotypic factors associated with good or poor response to treatment in precisely phenotyped AMD patients.


Secondary Outcome Measures :
  1. Predictive markers [ Time Frame: 6 months ]
    Look for predictive markers of cure response among polymorphisms that are susceptibility factors for AMD

  2. 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

  3. Environmental factors [ Time Frame: 6 months ]
    Look for predictive markers of treatment response among environmental factors

  4. 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

  5. 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.


Biospecimen Retention:   Samples With DNA
salivary swabs, venous sampling


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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Diagnosis of exudative or atrophic AMD
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03614481


Contacts
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Contact: Eric Soueid eric.souied@chicreteil.fr

Locations
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France
Hôpital Pellegrin Recruiting
Bordeaux, France, 33000
Contact: Jean-François Korobelnik, MD, PhD       jean-francois.korobelnik@chu-bordeaux.fr   
CHI Créteil Recruiting
Créteil, France, 94000
Contact: Eric Soueid         
Hôpital général de Dijon Recruiting
Dijon, France, 21033
Contact: Catherine Creuzot-Garcher, MD PhD       catherine.creuzot-garcher@chu-dijon.fr   
Hôpital des Quinze-Vingts Recruiting
Paris, France, 75012
Contact: José-Alain Sahel, MD PhD       j.sahel@gmail.com   
Centre ophtalmologique d'imagerie et de laser Recruiting
Paris, France
Contact: Cohen         
Sponsors and Collaborators
Centre Hospitalier Intercommunal Creteil
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Responsible Party: Centre Hospitalier Intercommunal Creteil
ClinicalTrials.gov Identifier: NCT03614481    
Other Study ID Numbers: COLLECTION DMLA
2013-A00110-45 ( Other Identifier: ID-RCB )
First Posted: August 3, 2018    Key Record Dates
Last Update Posted: August 4, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases