Age-related Macular DegenerationFATTYNCT04278300
Study of the Discriminating Power of a Blood Biomarker for Omega-3 Polyunsaturated Fatty Acid Content of the Retina for Age-related Macular Degeneration (AMD)
An observational study of Age-related Macular Degeneration, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
Age-related macular degeneration is a chronic degenerative retinal disease, which can lead to a progressive loss of visual acuity without affecting peripheral vision. It is a public health problem as it remains the leading cause of visual impairment in people over 50 years of age in industrialized countries. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Age-related Macular Degeneration
- What is being tested?
- blood sampling and faecal sampling (optional)
- How many people
- 205 participants
- Where
- 1 siteFrance
- Study dates
- 11 Feb 2020to 9 Sep 2020
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients coming for consultation in the ophthalmology department
Who may be able to join
- Subject who has provided written informed consent for participation in the study and genetic analyses
- Subject aged 50 years or older
- Subject with exudative AMD or
- Subject with macular disorder requiring cataract surgery
Who cannot join
- Person not affiliated to the national health insurance system
- Protected adults (curatorship, guardianship)
- Persons deprived of their liberty by judicial or administrative decision
- Adult unable to express consent
- Subject who has already participated in the study
- Subject with pre-existing maculopathy not labelled AMD
Show all 15Show fewer
- Subject refusing blood sample
- Subject with diabetes
- Subject on antibiotics or having had an antibiotic treatment in the last 3 months
- Subject with a BMI < 18.5 or > 30 kg/m2
- Subject with extreme eating habits (veganism, bulimia, anorexia)
- Subject currently on a diet with avoidance of certain types of food or a low-calorie diet
- Subject with an inflammatory disease (especially digestive disease)
- Subject having undergone bariatric surgery
- Subject having digestive tract malformations
Trial locations and contacts
1 site in 1 country.
About this study
Age-related macular degeneration is a chronic degenerative retinal disease, which can lead to a progressive loss of visual acuity without affecting peripheral vision. It is a public health problem as it remains the leading cause of visual impairment in people over 50 years of age in industrialized countries.
Age-related macular degeneration has two clinical forms:
Read more
- Atrophic or dry form: progressive disappearance of photoreceptors, alteration of the pigmentary epithelium leading to a thinning of the macula.
- Exudative or humid form: development of immature choroidal neo-vessels, leading to the formation of edema or intra or sub-retinal hemorrhage at the origin of the symptoms.
There are still many questions about the pathogenesis of age-related macular degeneration, and there is currently no etiological treatment. The disorder is thought to have a multifactorial, genetic and environmental origin.
Among the environmental risk factors, dietary intake of omega-3 polyunsaturated acids and its effect on the retina are factors that influence both the incidence and progression of the disease. However, intervention studies have not been able to demonstrate the preventive value of omega-3 polyunsaturated fatty acids. It is likely that the precise identification of patients who could benefit from this supplementation is necessary. Currently, the estimation of dietary intake of omega-3 polyunsaturated fatty acids is based on dietary surveys, which implies a number of limits. A blood biomarker of omega-3 polyunsaturated fatty acid content in the retina has been previously identified, which if lowered may be a risk factor for age-related macular degeneration. A low level could also help to identify patients who would best respond to supplementation. A publication has been submitted and a patent has been filed for this biomarker. The objective of this project is to confirm the relationship between this biomarker and the presence of age-related macular degeneration. The analysis will be refined by correlating the discriminating character of the biomarker with factors that may influence the intestinal metabolism of dietary lipids and their bioavailability in the blood. For this purpose, the status of the subjects with regard to their intestinal flora (microbiota) will be evaluated. The relationship between lipid metabolism, microbiota and age-related macular degeneration should also provide a better understanding of the pathophysiological mechanisms that link diet, lipid metabolism and age-related macular degeneration.
- Conditions
- Age-related Macular Degeneration
- Being tested
- blood sampling, faecal sampling (optional)
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplingBiological
dosage of omega 3 polyunsaturated fatty acids, search for age-related macular degeneration susceptibility genese
faecal sampling (optional)Biological
analysis of the microbiota by DNA sequencing
| Study group | Role | What they receive |
|---|---|---|
| case | patient with age-related exudative macular degeneration Receives: Biological: blood sampling; Biological: faecal sampling (optional) | |
| control | Patient with no macular disorder and in need of cataract surgery Receives: Biological: blood sampling; Biological: faecal sampling (optional) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retinal Omega-3 polyunsaturated fatty acid levels
Measured: at inclusion
Secondary outcomes (1)
Intestinal bacterial population levels
Measured: at inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2020
- Study start11 Feb 2020
- Primary completion21 Aug 2020
- Study completion9 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-related Macular DegenerationStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 205 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04278300
- Sponsor's protocol ID
- CREUZOT 2019
- Acronym
- FATTY
- Status last verified
- Nov 2020
- First submitted
- 18 Feb 2020
- Last updated
- 24 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Discriminating Power of a Blood Biomarker for Omega-3 Polyunsaturated Fatty Acid Content of the Retina for Age-related Macular Degeneration (AMD)
- ClinicalTrials.gov ID
- NCT04278300
- Acronym / sponsor ID
- FATTY / CREUZOT 2019
- Conditions
- Age-related Macular Degeneration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 205 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 11 Feb 2020 (actual)
- Primary completion
- 21 Aug 2020 (actual)
- Study completion
- 9 Sep 2020 (actual)
- First posted
- 20 Feb 2020 (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.
Age-related macular degeneration is a chronic degenerative retinal disease, which can lead to a progressive loss of visual acuity without affecting peripheral vision. It is a public health problem as it remains the leading cause of visual impairment in people over 50 years of age in industrialized countries.
Age-related macular degeneration has two clinical forms:
- Atrophic or dry form: progressive disappearance of photoreceptors, alteration of the pigmentary epithelium leading to a thinning of the macula.
- Exudative or humid form: development of immature choroidal neo-vessels, leading to the formation of edema or intra or sub-retinal hemorrhage at the origin of the symptoms.
There are still many questions about the pathogenesis of age-related macular degeneration, and there is currently no etiological treatment. The disorder is thought to have a multifactorial, genetic and environmental origin.
Among the environmental risk factors, dietary intake of omega-3 polyunsaturated acids and its effect on the retina are factors that influence both the incidence and progression of the disease. However, intervention studies have not been able to demonstrate the preventive value of omega-3 polyunsaturated fatty acids. It is likely that the precise identification of patients who could benefit from this supplementation is necessary. Currently, the estimation of dietary intake of omega-3 polyunsaturated fatty acids is based on dietary surveys, which implies a number of limits. A blood biomarker of omega-3 polyunsaturated fatty acid content in the retina has been previously identified, which if lowered may be a risk factor for age-related macular degeneration. A low level could also help to identify patients who would best respond to supplementation. A publication has been submitted and a patent has been filed for this biomarker. The objective of this project is to confirm the relationship between this biomarker and the presence of age-related macular degeneration. The analysis will be refined by correlating the discriminating character of the biomarker with factors that may influence the intestinal metabolism of dietary lipids and their bioavailability in the blood. For this purpose, the status of the subjects with regard to their intestinal flora (microbiota) will be evaluated. The relationship between lipid metabolism, microbiota and age-related macular degeneration should also provide a better understanding of the pathophysiological mechanisms that link diet, lipid metabolism and age-related macular degeneration.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| case | – | Biological: blood sampling, Biological: faecal sampling (optional)patient with age-related exudative macular degeneration |
| control | – | Biological: blood sampling, Biological: faecal sampling (optional)Patient with no macular disorder and in need of cataract surgery |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients coming for consultation in the ophthalmology department
Key inclusion criteria (4 listed)
- Subject who has provided written informed consent for participation in the study and genetic analyses
- Subject aged 50 years or older
- Subject with exudative AMD or
- Subject with macular disorder requiring cataract surgery
Key exclusion criteria (15 listed)
- Person not affiliated to the national health insurance system
- Protected adults (curatorship, guardianship)
- Persons deprived of their liberty by judicial or administrative decision
- Adult unable to express consent
- Subject who has already participated in the study
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 |
|---|---|---|
| blood samplingdosage of omega 3 polyunsaturated fatty acids, search for age-related macular degeneration susceptibility genese | Biological | case, control |
| faecal sampling (optional)analysis of the microbiota by DNA sequencing | Biological | case, control |
Primary outcome
Retinal Omega-3 polyunsaturated fatty acid levels
Time frame: at inclusion
1 secondary outcome
Intestinal bacterial population levels
Time frame: at inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Age-related Macular Degeneration, run by Centre Hospitalier Universitaire Dijon at 1 site 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 15 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: finished, as of the sponsor's last update on 24 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retinal Omega-3 polyunsaturated fatty acid levels (time frame: at inclusion). 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 24 Nov 2020.