Clinical and Genetic Analyzes of Age-related Macular Degeneration (COLDMLA)
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|ClinicalTrials.gov Identifier: NCT03614481|
Recruitment Status : Recruiting
First Posted : August 3, 2018
Last Update Posted : August 4, 2020
|Condition or disease||Intervention/treatment|
|Macular Degeneration||Genetic: Sampling|
|Study Type :||Observational|
|Estimated Enrollment :||6000 participants|
|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|
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.
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.
- Genotypic factors [ Time Frame: 6 months ]Identification of genotypic factors associated with good or poor response to treatment in precisely phenotyped AMD patients.
- 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.
Biospecimen Retention: Samples With DNA
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
|Contact: Eric Soueidfirstname.lastname@example.org|
|Bordeaux, France, 33000|
|Contact: Jean-François Korobelnik, MD, PhD email@example.com|
|Créteil, France, 94000|
|Contact: Eric Soueid|
|Hôpital général de Dijon||Recruiting|
|Dijon, France, 21033|
|Contact: Catherine Creuzot-Garcher, MD PhD firstname.lastname@example.org|
|Hôpital des Quinze-Vingts||Recruiting|
|Paris, France, 75012|
|Contact: José-Alain Sahel, MD PhD email@example.com|
|Centre ophtalmologique d'imagerie et de laser||Recruiting|