COLDMLA: Clinical and Genetic Analyzes of Age-related Macular Degeneration

Sponsor

Centre Hospitalier Intercommunal Creteil (Other)

Overall Status

Recruiting

CT.gov ID

NCT03614481

Collaborator

(none)

6,000

Enrollment

Locations

204

Anticipated Duration (Months)

1200

Patients Per Site

5.9

Patients Per Site Per Month

Study Details

Study Description

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	Phase
Macular Degeneration	Genetic: Sampling

Study Design

Study Type:

Observational

Anticipated Enrollment :

6000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Clinical and Genetic Analyzes of Age-related Macular Degeneration

Actual Study Start Date :

Nov 1, 2005

Anticipated Primary Completion Date :

Nov 1, 2022

Anticipated Study Completion Date :

Nov 1, 2022

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Genotypic factors [6 months]
Identification of genotypic factors associated with good or poor response to treatment in precisely phenotyped AMD patients.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years and Older

Sexes Eligible for Study:

All

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Hôpital Pellegrin	Bordeaux	France	33000
2	CHI Créteil	Créteil	France	94000
3	Hôpital général de Dijon	Dijon	France	21033
4	Hôpital des Quinze-Vingts	Paris	France	75012
5	Centre ophtalmologique d'imagerie et de laser	Paris	France

Sponsors and Collaborators

Centre Hospitalier Intercommunal Creteil

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Intercommunal Creteil

ClinicalTrials.gov Identifier:

NCT03614481

Other Study ID Numbers:

COLLECTION DMLA
2013-A00110-45

First Posted:

Aug 3, 2018

Last Update Posted:

Aug 4, 2020

Last Verified:

Jul 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Macular Degeneration

Study Results

No Results Posted as of Aug 4, 2020