Clinical and Genetic Analyzes of Age-related Macular Degeneration

Macular Degeneration Clinical Trial

— COLDMLA  

Official title:

Clinical and Genetic Analyzes of Age-related Macular Degeneration

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03614481
• Other study ID #: COLLECTION DMLA
• Secondary ID: 2013-A00110-45
• Status: Recruiting
• Start date: November 2005
• Est. completion date: November 2024

Study information

• Verified date: May 2023
• Source: Centre Hospitalier Intercommunal Creteil
• Contact: Eric Soueid
• Email: eric.souied[@]chicreteil.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6000
• Est. completion date: November 2024
• Est. primary completion date: November 2024
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Macular Degeneration

Intervention

Genetic:
• Sampling
Sampling

Locations

Country	Name	City	State
France	Hôpital Pellegrin	Bordeaux
France	CHI Créteil	Créteil
France	Hôpital général de Dijon	Dijon
France	Centre ophtalmologique d'imagerie et de laser	Paris
France	Hôpital des Quinze-Vingts	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Intercommunal Creteil

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Genotypic factors	Identification of genotypic factors associated with good or poor response to treatment in precisely phenotyped AMD patients.	6 months
Secondary	Predictive markers	Look for predictive markers of cure response among polymorphisms that are susceptibility factors for AMD	6 months
Secondary	Vascular Endothelial Growth Factor	Look for predictors of treatment response among polymorphisms of other genes: Vascular Endothelial Growth Factor, Vascular Endothelial Growth Factor Receptor	6 months
Secondary	Environmental factors	Look for predictive markers of treatment response among environmental factors	6 months
Secondary	Predictive treatment response score	Create a predictive treatment response score that combines factors independently associated with the response to treatment in multivariate analysis	6 months
Secondary	Circulating biological factors	Identification of circulating biological factors such as circulating fatty acids at risk of AMD or modulating the response to treatment.	6 months