Clinical and Genetic Analyzes of Age-related Macular Degeneration

NCT ID: NCT03614481

Last Updated: 2023-05-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

6000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-11-30

Study Completion Date

2024-11-30

Brief Summary

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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

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Conditions

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Macular Degeneration

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Sampling

Intervention Type 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.

Sampling

Intervention Type GENETIC

Sampling

Interventions

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Sampling

Sampling

Intervention Type GENETIC

Eligibility Criteria

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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
Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Intercommunal Creteil

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hôpital Pellegrin

Bordeaux, , France

Site Status RECRUITING

CHI Créteil

Créteil, , France

Site Status RECRUITING

Hôpital général de Dijon

Dijon, , France

Site Status RECRUITING

Hôpital des Quinze-Vingts

Paris, , France

Site Status RECRUITING

Centre ophtalmologique d'imagerie et de laser

Paris, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Eric Soueid

Role: CONTACT

Facility Contacts

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Jean-François Korobelnik, MD, PhD

Role: primary

Eric Soueid

Role: primary

Catherine Creuzot-Garcher, MD PhD

Role: primary

José-Alain Sahel, MD PhD

Role: primary

Cohen

Role: primary

Other Identifiers

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2013-A00110-45

Identifier Type: OTHER

Identifier Source: secondary_id

COLLECTION DMLA

Identifier Type: -

Identifier Source: org_study_id

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