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

C

Centre Hospitalier Intercommunal Creteil

Status

Enrolling

Conditions

Macular Degeneration

Treatments

Genetic: Sampling

Study type

Observational

Funder types

Other

Identifiers

NCT03614481
2013-A00110-45 (Other Identifier)
COLLECTION DMLA

Details and patient eligibility

About

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).

Enrollment

6,000 estimated patients

Sex

All

Ages

55+ years old

Volunteers

No Healthy Volunteers

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

Trial design

6,000 participants in 2 patient groups

AMD patient
Description:
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.
Treatment:
Genetic: Sampling
control without AMD
Description:
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.
Treatment:
Genetic: Sampling

Trial contacts and locations

5

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Central trial contact

Eric Soueid

Data sourced from clinicaltrials.gov

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