Macular DegenerationMACUTESTNCT05675917
MacuTest Website for Personalized AMD Risk Prediction and Prevention
A study testing MacuTest platform in people with Macular Degeneration, run by University Hospital, Bordeaux.
Trial summary
LEHA team of Bordeaux University has developed an Age-related Macular Degeneration (AMD) prediction algorithm (taking into account age, 49 genetic variants, the presence of early retinal abnormalities, tobacco consumption, food quality, blood pressure and education level) and is currently developing the MacuTest… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Macular Degeneration
- What is being tested?
- MacuTest platform
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 2 Feb 2024to 2 Feb 2024
- Phase
- Interventional
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Patients aged 65 years and older of European geographic origin
- Presence of early signs of AMD (drusen and/or pigment abnormalities) and/or parents with advanced AMD.
- Absence of any advanced form of AMD (atrophic or neovascular AMD).
- Patient who can read, understand and speak French.
- Patient with access to the MacuTest internet platform throughout the study (telephone, tablet, computer).
- Patient with the ability and willingness to carry out all planned visits and assessments.
- Patient with health insurance.
- Signed informed consent.
Who cannot join
- Presence of a severe ocular pathology that prevents an examination of the fundus.
- Patient with a history of a medical condition that, in the opinion of the investigator, would prevent the completion of scheduled study visits and completion of the study.
- Adult under legal protection or residing in a health or social institution.
About this study
Official title: Feasibility and Acceptability of the MacuTest Website for Personalized AMD Risk Prediction and Prevention: Pilot Study
LEHA team of Bordeaux University has developed an Age-related Macular Degeneration (AMD) prediction algorithm (taking into account age, 49 genetic variants, the presence of early retinal abnormalities, tobacco consumption, food quality, blood pressure and education level) and is currently developing the MacuTest website, integrating this prediction algorithm. This platform offers participants the possibility to enter their personal lifestyle data, to couple them with an ophthalmological examination and a genetic test, in order to evaluate their personalized risk of AMD. The main objective of this pilot study is to evaluate the feasibility of estimating the predicted AMD risk
Read the detailed description
AMD is the leading cause of blindness in industrialized countries. Current treatments only address the neovascular form and do not always prevent vision loss. This multifactorial pathology involves both genetic factors (more than 50 loci identified) and environmental factors. The genes identified suggest an important contribution of inflammation and innate immunity as well as lipid metabolism in the physiopathology of AMD. As a potential target for preventive actions, the role of lifestyle has also been the subject of much work. Thus, epidemiological studies have identified smoking as an important risk factor. The role of nutrition and metabolism in ocular aging is of growing interest, with hypotheses focusing more specifically on the joint effect of antioxidants and lipids. It is therefore important to develop prevention strategies. In this context, it is necessary to be able to identify at an early stage those people most at risk of developing AMD, in order to propose interventions aimed at reducing the risk of visual loss (reinforced ophthalmological follow-up for rapid detection and treatment of neovascular forms, lifestyle recommendations, nutritional supplementation, etc.).
During the baseline (V1) and the 12-months follow-up (V3) visits, lifestyle data (tobacco, diet, education) will be collected within online self-questionnaires on the MacuTest platform. Ophthalmological examination with evaluation of retinal anomalies, blood pressure, and saliva collection (inclusion only) for genetic testing will be perform by the ophthalmologist.
At the 6-months follow-up visit (V2), the ophthalmologist will give the participant the results of the genetic test and explanations and interpretation of the results he or she deems necessary.
At the 12-months follow-up visit (V3), the participant will fill in a questionnaire to evaluate the MacuTest platform.
- Conditions
- Macular Degeneration
- Being tested
- MacuTest platform
- Keywords
- Macular degeneration, prediction, digital platform, personalized medicine
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MacuTest platformDevice
The MacuTest platform will be used to collect the data needed to predict AMD risk. AMD risk prediction is evaluated by a mathematical algorithm based on the data collected and integrated into the platform.
The ophthalmologist will fill in the ophthalmologist questionnaire in the platform with data on the fundus and blood pressure, after examining the patient.
The patient will fill in the lifestyle questionnaires (nutrition, smoking, gender, year of birth, level of education) with his personal equipment (computer, smartphone or tablet).
| Study group | Role | What they receive |
|---|---|---|
| MacuTest website | Experimental | The MacuTest platform will be used to collect the data needed to predict AMD risk. AMD risk prediction is evaluated by a mathematical algorithm based on the data collected and integrated into the platform.
The ophthalmologist will fill in the ophthalmologist questionnaire in the platform with data on the fundus and blood pressure, after examining the patient.
The patient will fill in the lifestyle questionnaires (nutrition, smoking, gender, year of birth, level of education) with his personal equipment (computer, smartphone or tablet). Receives: Device: MacuTest platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
estimation of AMD risk
Percentage of participants who received an estimation of their risk of AMD
Measured: Month 6
Secondary outcomes (4)
Socio-demographic characteristics
Socio-demographic characteristics (age, gender, education level)
Measured: baseline
Lifestyle characteristics
Lifestyle characteristics (tobacco use, diet quality)
Measured: baseline
Ophthalmological characteristics
Ophthalmological characteristics (presence of drusen, pigmentary abnormalities, advanced AMD in each eye)
Measured: baseline
Genetic risk
Evaluated by the presence or not of the following variants: CFH_rs187328863 ; CFH_rs570618 ; CFH_rs148553336 ; CFH_rs10922109 ; CFH_rs35292876 ; CFH_rs121913059 ; CFH_rs61818925 ; CFH_rs191281603 ; COL4A3_rs11884770 ; ADAMTS9_rs62247658 ; COL8A1_rs140647181 ; COL8A1_rs55975637 ; CFI_rs10033900 ; CFI_rs141853578 ; PRLR_SPEF2_rs114092250 ; C9_rs62358361 ; C2_rs144629244 ; C2_rs429608 ; C2_rs181705462 ; C2_rs114254831 ; C2_rs943080 ; PILRB_rs7803454 ; KMT2E_rs1142 ; TNFRSF10A_rs79037040 ; MIR6130_rs10781182 ; TGFBR1_rs1626340 ; ABCA1_rs2740488 ; ARHGAP21_rs12357257 ; ARMS2_rs3750846 ; RDH5_rs3138141 ; ACAD10_rs61941274 ; B3GALTL_rs9564692 ; RAD51B_rs61985136 ; RAD51B_rs2842339 ; LIPC_rs2043085 ; LIPC_rs2070895 ; CETP_rs17231506 ; CETP_rs5817082 ; CTRB2_rs72802342 ; TMEM97_rs11080055 ; NPLOC4_rs6565597 ; C3_rs12019136 ; C3_rs147859257 ; C3_rs2230199 ; APOE_rs429358 ; APOE_rs73036519 ; C20orf85_rs201459901_ ; SYN3_rs5754227 ; SLC16A8_rs8135665 ;
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2023
- Study start2 Feb 2024
- Primary completion2 Feb 2024
- Study completion2 Feb 2024
Why it stopped: Administrative issues
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.
- More trials run by University Hospital, BordeauxThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bordeaux
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05675917
- Sponsor's protocol ID
- CHUBX 2022/46
- Acronym
- MACUTEST
- Status last verified
- Feb 2024
- First submitted
- 28 Dec 2022
- Last updated
- 12 Feb 2024
- 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 12 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Acceptability of the MacuTest Website for Personalized AMD Risk Prediction and Prevention: Pilot Study
- ClinicalTrials.gov ID
- NCT05675917
- Acronym / sponsor ID
- MACUTEST / CHUBX 2022/46
- Conditions
- Macular Degeneration
- Keywords
- Macular degeneration, prediction, digital platform, personalized medicine
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Administrative issues
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- University of Bordeaux
- Study start
- 2 Feb 2024 (actual)
- Primary completion
- 2 Feb 2024 (actual)
- Study completion
- 2 Feb 2024 (actual)
- First posted
- 9 Jan 2023 (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.
LEHA team of Bordeaux University has developed an Age-related Macular Degeneration (AMD) prediction algorithm (taking into account age, 49 genetic variants, the presence of early retinal abnormalities, tobacco consumption, food quality, blood pressure and education level) and is currently developing the MacuTest website, integrating this prediction algorithm. This platform offers participants the possibility to enter their personal lifestyle data, to couple them with an ophthalmological examination and a genetic test, in order to evaluate their personalized risk of AMD. The main objective of this pilot study is to evaluate the feasibility of estimating the predicted AMD risk
Detailed description
AMD is the leading cause of blindness in industrialized countries. Current treatments only address the neovascular form and do not always prevent vision loss. This multifactorial pathology involves both genetic factors (more than 50 loci identified) and environmental factors. The genes identified suggest an important contribution of inflammation and innate immunity as well as lipid metabolism in the physiopathology of AMD. As a potential target for preventive actions, the role of lifestyle has also been the subject of much work. Thus, epidemiological studies have identified smoking as an important risk factor. The role of nutrition and metabolism in ocular aging is of growing interest, with hypotheses focusing more specifically on the joint effect of antioxidants and lipids. It is therefore important to develop prevention strategies. In this context, it is necessary to be able to identify at an early stage those people most at risk of developing AMD, in order to propose interventions aimed at reducing the risk of visual loss (reinforced ophthalmological follow-up for rapid detection and treatment of neovascular forms, lifestyle recommendations, nutritional supplementation, etc.).
During the baseline (V1) and the 12-months follow-up (V3) visits, lifestyle data (tobacco, diet, education) will be collected within online self-questionnaires on the MacuTest platform. Ophthalmological examination with evaluation of retinal anomalies, blood pressure, and saliva collection (inclusion only) for genetic testing will be perform by the ophthalmologist.
At the 6-months follow-up visit (V2), the ophthalmologist will give the participant the results of the genetic test and explanations and interpretation of the results he or she deems necessary.
At the 12-months follow-up visit (V3), the participant will fill in a questionnaire to evaluate the MacuTest platform.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MacuTest website | Experimental | Device: MacuTest platformThe MacuTest platform will be used to collect the data needed to predict AMD risk. AMD risk prediction is evaluated by a mathematical algorithm based on the data collected and integrated into the platform. The ophthalmologist will fill in the ophthalmologist questionnaire in the platform with data on the fundus and blood pressure, after examining the patient. The patient will fill in the lifestyle questionnaires (nutrition, smoking, gender, year of birth, level of education) with his personal equipment (computer, smartphone or tablet). |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- Patients aged 65 years and older of European geographic origin
- Presence of early signs of AMD (drusen and/or pigment abnormalities) and/or parents with advanced AMD.
- Absence of any advanced form of AMD (atrophic or neovascular AMD).
- Patient who can read, understand and speak French.
- Patient with access to the MacuTest internet platform throughout the study (telephone, tablet, computer).
Key exclusion criteria (3 listed)
- Presence of a severe ocular pathology that prevents an examination of the fundus.
- Patient with a history of a medical condition that, in the opinion of the investigator, would prevent the completion of scheduled study visits and completion of the study.
- Adult under legal protection or residing in a health or social institution.
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 |
|---|---|---|
| MacuTest platformThe MacuTest platform will be used to collect the data needed to predict AMD risk. AMD risk prediction is evaluated by a mathematical algorithm based on the data collected and integrated into the platform. The ophthalmologist will fill in the ophthalmologist questionnaire in the platform with data on the fundus and blood pressure, after examining the patient. The patient will fill in the lifestyle questionnaires (nutrition, smoking, gender, year of birth, level of education) with his personal equipment (computer, smartphone or tablet). | Device | MacuTest website |
Primary outcome
estimation of AMD risk
Time frame: Month 6
Percentage of participants who received an estimation of their risk of AMD
4 secondary outcomes
Socio-demographic characteristics
Time frame: baseline
Lifestyle characteristics
Time frame: baseline
Ophthalmological characteristics
Time frame: baseline
Genetic risk
Time frame: baseline
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2024.
- Individual participant dataSharing planned: No
Related trials for Macular Degeneration
RecruitingObservational study
Cell Collection to Study Eye Diseases
Retinal Disease, AMD
Not yet recruiting
MacuMira Microcurrent Stimulation for Dark Adaptation in Dry Age-Related Macular Degeneration
Age-Related Macular Degeneration (AMD)
Not yet recruiting
Safety and Clinical Performance of the LENTIS® MAX LS-313 MF80 Compared With the Monofocal L-313 in Cataract Patients With Late Age-Related Macular Degeneration: A Multicenter Comparative Clinical Investigation.
Cataract, AMD - Age-Related Macular Degeneration
RecruitingPhase 1
Safety and Efficacy Study of IVB103 Injection in Subjects With Neovascular (Wet) Agerelated Macular Degeneration (nAMD).
nAMD
RecruitingPhase 2
Safety and Efficacy of AIV007 Periocular Injection in Patients With Neovascular Age-Related Macular Degeneration
Neovascular (Wet) Age-Related Macular Degeneration
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.
Questions about this trial
What is this clinical trial studying?
A study testing MacuTest platform in people with Macular Degeneration, run by University Hospital, Bordeaux.
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 8 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: withdrawn, as of the sponsor's last update on 12 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
estimation of AMD risk (time frame: Month 6). 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 12 Feb 2024.