Clinical and Genetic Analyzes of Age-related Macular Degeneration

Recruiting

• Conditions: Macular Degeneration

• Registration Number: NCT03614481
• Lead Sponsor: Centre Hospitalier Intercommunal Creteil

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2005-11
• Study First Submitted: 2018-07-30
• Study First Submitted QC: 2018-07-30
• Study First Posted: 2018-08-03
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-12
• Last Update Posted: 2023-05-15
• Primary Completion: 2024-11
• Study Completion: 2024-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 6000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Environmental factors	6 months	Look for predictive markers of treatment response among environmental factors
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.
Predictive markers	6 months	Look for predictive markers of cure response among polymorphisms that are susceptibility factors for AMD
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
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

Trial Locations

Locations (5)

Hôpital Pellegrin; 🇫🇷 Bordeaux, France

CHI Créteil; 🇫🇷 Créteil, France

Hôpital général de Dijon; 🇫🇷 Dijon, France

Hôpital des Quinze-Vingts; 🇫🇷 Paris, France

Centre ophtalmologique d'imagerie et de laser; 🇫🇷 Paris, France