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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

Tracking Information
First Submitted Date July 30, 2018
First Posted Date August 3, 2018
Last Update Posted Date August 4, 2020
Actual Study Start Date November 2005
Estimated Primary Completion Date November 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 30, 2018)
Genotypic factors [ Time Frame: 6 months ]
Identification of genotypic factors associated with good or poor response to treatment in precisely phenotyped AMD patients.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 30, 2018)
  • Predictive markers [ Time Frame: 6 months ]
    Look for predictive markers of cure response among polymorphisms that are susceptibility factors for AMD
  • 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
  • Environmental factors [ Time Frame: 6 months ]
    Look for predictive markers of treatment response among environmental factors
  • 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
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Clinical and Genetic Analyzes of Age-related Macular Degeneration
Official Title Clinical and Genetic Analyzes of Age-related Macular Degeneration
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).
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
salivary swabs, venous sampling
Sampling Method Non-Probability Sample
Study Population Diagnosis of exudative or atrophic AMD
Condition Macular Degeneration
Intervention Genetic: Sampling
Sampling
Study Groups/Cohorts
  • 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.

    Intervention: Genetic: 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.

    Intervention: Genetic: Sampling
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 30, 2018)
6000
Original Estimated Enrollment Same as current
Estimated Study Completion Date November 2022
Estimated Primary Completion Date November 2022   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 55 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: Eric Soueid eric.souied@chicreteil.fr
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03614481
Other Study ID Numbers COLLECTION DMLA
2013-A00110-45 ( Other Identifier: ID-RCB )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Centre Hospitalier Intercommunal Creteil
Study Sponsor Centre Hospitalier Intercommunal Creteil
Collaborators Not Provided
Investigators Not Provided
PRS Account Centre Hospitalier Intercommunal Creteil
Verification Date July 2020