NCT03614481

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
6,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2005

Longer than P75 for all trials

Geographic Reach
1 country

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
12.8 years until next milestone

First Submitted

Initial submission to the registry

July 30, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 3, 2018

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2024

Completed
Last Updated

May 15, 2023

Status Verified

May 1, 2023

Enrollment Period

19 years

First QC Date

July 30, 2018

Last Update Submit

May 12, 2023

Conditions

Macular Degeneration

Outcome Measures

Primary Outcomes (1)

  • Genotypic factors

    Identification of genotypic factors associated with good or poor response to treatment in precisely phenotyped AMD patients.

    6 months

Secondary Outcomes (5)

  • Predictive markers

    6 months

  • Vascular Endothelial Growth Factor

    6 months

  • Environmental factors

    6 months

  • Predictive treatment response score

    6 months

  • Circulating biological factors

    6 months

Study Arms (2)

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

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

Interventions

SamplingGENETIC

Sampling

AMD patientcontrol without AMD

Eligibility Criteria

Age55 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Diagnosis of exudative or atrophic AMD

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Hôpital Pellegrin

Bordeaux, 33000, France

RECRUITING

CHI Créteil

Créteil, 94000, France

RECRUITING

Hôpital général de Dijon

Dijon, 21033, France

RECRUITING

Hôpital des Quinze-Vingts

Paris, 75012, France

RECRUITING

Centre ophtalmologique d'imagerie et de laser

Paris, France

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

salivary swabs, venous sampling

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Central Study Contacts

Eric Soueid

CONTACT

eric.souied@chicreteil.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2018

First Posted

August 3, 2018

Study Start

November 1, 2005

Primary Completion

November 1, 2024

Study Completion

November 1, 2024

Last Updated

May 15, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

FR(5)