Macular DegenerationCOLDMLANCT03614481
Clinical and Genetic Analyzes of Age-related Macular Degeneration
An observational study of Macular Degeneration, run by Centre Hospitalier Intercommunal Creteil at 5 sites in France.
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). Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Macular Degeneration
- What is being tested?
- Sampling
- How many people
- 6,000 participants
- Where
- 5 sitesFrance
- Study dates
- Nov 2005to Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- Adult, Older adult
Study population: Diagnosis of exudative or atrophic AMD
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
Eric Soueid contact
5 sites in 1 country
France5 sites, 5 recruiting
- Recruiting
Hôpital Pellegrin
Bordeaux, 33000
Jean-François Korobelnik, MD, PhD, jean-francois.korobelnik@chu-bordeaux.fr
- Recruiting
CHI Créteil
Créteil, 94000
Eric Soueid
- Recruiting
Hôpital général de Dijon
Dijon, 21033
Catherine Creuzot-Garcher, MD PhD, catherine.creuzot-garcher@chu-dijon.fr
- Recruiting
Hôpital des Quinze-Vingts
Paris, 75012
José-Alain Sahel, MD PhD, j.sahel@gmail.com
- Recruiting
Centre ophtalmologique d'imagerie et de laser
Paris
Cohen
About this study
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).
- Conditions
- Macular Degeneration
- Being tested
- Sampling
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SamplingGenetic
Sampling
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Genetic: Sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Genotypic factors
Identification of genotypic factors associated with good or poor response to treatment in precisely phenotyped AMD patients.
Measured: 6 months
Secondary outcomes (5)
Predictive markers
Look for predictive markers of cure response among polymorphisms that are susceptibility factors for AMD
Measured: 6 months
Vascular Endothelial Growth Factor
Look for predictors of treatment response among polymorphisms of other genes: Vascular Endothelial Growth Factor, Vascular Endothelial Growth Factor Receptor
Measured: 6 months
Environmental factors
Look for predictive markers of treatment response among environmental factors
Measured: 6 months
Predictive treatment response score
Create a predictive treatment response score that combines factors independently associated with the response to treatment in multivariate analysis
Measured: 6 months
Circulating biological factors
Identification of circulating biological factors such as circulating fatty acids at risk of AMD or modulating the response to treatment.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2018
- Study startNov 2005
- Primary completionNov 2024 (estimated)
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal Creteil
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03614481
- Sponsor's protocol ID
- COLLECTION DMLA
- Other IDs
- 2013-A00110-45
- Acronym
- COLDMLA
- Status last verified
- May 2023
- First submitted
- 30 Jul 2018
- Last updated
- 15 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Genetic Analyzes of Age-related Macular Degeneration
- ClinicalTrials.gov ID
- NCT03614481
- Acronym / sponsor ID
- COLDMLA / COLLECTION DMLA
- Conditions
- Macular Degeneration
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- Centre Hospitalier Intercommunal CreteilUniversity, hospital or other
- Study start
- Nov 2005 (actual)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 3 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AMD patient | – | Genetic: SamplingDuring 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 | – | Genetic: Sampling898/5000 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. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Diagnosis of exudative or atrophic AMD
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SamplingSampling | Genetic | AMD patient, control without AMD |
Primary outcome
Genotypic factors
Time frame: 6 months
Identification of genotypic factors associated with good or poor response to treatment in precisely phenotyped AMD patients.
5 secondary outcomes
Predictive markers
Time frame: 6 months
Vascular Endothelial Growth Factor
Time frame: 6 months
Environmental factors
Time frame: 6 months
Predictive treatment response score
Time frame: 6 months
Circulating biological factors
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Soueid contact
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Macular Degeneration, run by Centre Hospitalier Intercommunal Creteil at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eric Soueid (eric.souied@chicreteil.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Genotypic factors (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2023.