Age-Related Macular DegenerationAMDAYNCT06333873
Impact of Age-related Macular Degeneration on Daily Living Activitie
A study testing patient-reported outcome in people with Age-Related Macular Degeneration, run by Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts.
Trial summary
The complex and variable course of age-related diseases makes it all the more necessary to carry out personalised, reasoning-based examinations to improve the personalised assessment and management of AMD. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Age-Related Macular Degeneration
- What is being tested?
- patient-reported outcome
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Jun 2024to Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- General criteria for healthy volunteers and AMD patients:
- Male / Female participant,
- Age ≥ 50 at inclusion,
- Able and willing to provide written informed consent and comply with the study protocol, visits and assessments,
- Quality of AO imaging as assessed by rtx1 camera, ● deemed adequate according to the study physician,
- Membership of a social security scheme or beneficiary of such a scheme.
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- Specific criteria for the AMD group:
- Geriatric Depression Scale (GDS) questionnaire score ≤ 10 A COGEVIS questionnaire score ≥ 24/30
- Visual acuity greater than 4/10ths
- General criteria for healthy volunteers:
- No detectable visual pathologies
- Best monocular visual acuity (corrected to 100% of the contrast) ≥ 8/10ths before age 70 and ≥ 6/10ths after.
- MMSE score ≥ 20
- Specific criteria for the group of healthy volunteers with central microdrusens:
- No detectable visual pathologies other than the presence of central microdrusens.
- Best monocular visual acuity (corrected to 100% contrast) ≥ 8/10th before age 70 and ≥ 6/10th after.
- MMSE score ≥ 20
Who cannot join
- Pregnant, parturient or breast-feeding women,
- Subjects taking medication likely to cause motor, visual, vestibular or cognitive disorders (PSA, neuroleptics, etc.) or who could interfere with the study examinations cannot be included in this study,
- Environmental opacity or eye movement disorders (nystagmus) which, in the opinion of the investigator, interfere with the quality of retinal imaging data.
- Any concomitant intraocular condition in the study eye (e.g. glaucoma or cataract) that, in the opinion of the investigator, would require surgical intervention during the study to prevent or treat vision loss that may result from this condition or affect the interpretation of study results,
- Known systemic disease which, in the opinion of the investigator, would preclude active participation in the study,
- Participation in any other therapeutic study evaluating a drug,
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- Cognitively impaired subjects, illiterate subjects and subjects who do not speak the national language.
- Subjects with dyslexic reading disorders,
- Subjects subject to a reinforced protection measure or legal safeguard (curatorship, guardianship).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Validation of Standardized Tasks and Questionnaires to Evaluate and Understand the Impact of Age-related Macular Degeneration on Daily Living Activitie
The complex and variable course of age-related diseases makes it all the more necessary to carry out personalised, reasoning-based examinations to improve the personalised assessment and management of AMD. However, functional assessment of AMD is most often based solely on visual acuity, and classifications of AMD are based solely on structural markers. There is therefore a need to improve the detection and functional assessment of this vision-threatening eye disease, by complementing and extending the standard assessments of clinical outcomes (COA)
Read the detailed description
Prospective, longitudinal, interventional, exploratory, non-randomised, single-centre study, including healthy volunteers and patients with Age-Related Macular Degeneration
- Conditions
- Age-Related Macular Degeneration
- Being tested
- patient-reported outcome
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patient-reported outcomeOther
Performance of real-life tests and tasks
| Study group | Role | What they receive |
|---|---|---|
| Patients with early-stage AMD | Other | 30Patients with early-stage AMD Receives: Other: patient-reported outcome |
| Patients with intermediate-stage AMD | Other | 30 with intermediate-stage AMD Receives: Other: patient-reported outcome |
| 30 healthy volunteers | Other | Without AMD risk Receives: Other: patient-reported outcome |
| 30 healthy volunteers with central microdrusens (at risk of developing AMD) | Other | with central microdrusens (at risk of developing AMD) Receives: Other: patient-reported outcome |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validity of criteria
Number of patients with capacity of discrimintaion compared to healthy volunteers.
ROC (receiver operating characteristic curve), which illustrates the diagnostic capacity of a binary classification system as a function of the variation in its discrimination threshold. The ROC curve is created by plotting the rate of true positives versus the false-positive rate for different thresholds. The index used to characterize a test's of a test is the air under the curve
Measured: 26 month
Validity of content
number of paticipants with capacity to execute questionnaires and daily real-life task
Measured: 26 month
Reproducibility of results
Number of patients able to reproduce the same performance tests
Measured: 26 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2024
- Study startJun 2024 (estimated)
- Primary completionJun 2029 (estimated)
- Study completionJun 2029 (estimated)
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.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Prospective, longitudinal, interventional, exploratory, non-randomised, single-centre study including healthy volunteers and patients with AMD
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michel PAQUES, Pr, Principal investigator, centre Hospitalier Nationald'Ophtalmologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06333873
- Sponsor's protocol ID
- P22-09
- Acronym
- AMDAY
- Status last verified
- Mar 2024
- First submitted
- 26 Jan 2024
- Last updated
- 27 Mar 2024
- 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 27 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Standardized Tasks and Questionnaires to Evaluate and Understand the Impact of Age-related Macular Degeneration on Daily Living Activitie
- ClinicalTrials.gov ID
- NCT06333873
- Acronym / sponsor ID
- AMDAY / P22-09
- Conditions
- Age-Related Macular Degeneration
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Centre Hospitalier National d'Ophtalmologie des Quinze-VingtsUniversity, hospital or other
- Study start
- Jun 2024 (estimated)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 27 Mar 2024 (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 complex and variable course of age-related diseases makes it all the more necessary to carry out personalised, reasoning-based examinations to improve the personalised assessment and management of AMD. However, functional assessment of AMD is most often based solely on visual acuity, and classifications of AMD are based solely on structural markers. There is therefore a need to improve the detection and functional assessment of this vision-threatening eye disease, by complementing and extending the standard assessments of clinical outcomes (COA)
Detailed description
Prospective, longitudinal, interventional, exploratory, non-randomised, single-centre study, including healthy volunteers and patients with Age-Related Macular Degeneration
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Prospective, longitudinal, interventional, exploratory, non-randomised, single-centre study including healthy volunteers and patients with AMD
| Arm | Type | Receives |
|---|---|---|
| Patients with early-stage AMD | Other | Other: patient-reported outcome30Patients with early-stage AMD |
| Patients with intermediate-stage AMD | Other | Other: patient-reported outcome30 with intermediate-stage AMD |
| 30 healthy volunteers | Other | Other: patient-reported outcomeWithout AMD risk |
| 30 healthy volunteers with central microdrusens (at risk of developing AMD) | Other | Other: patient-reported outcomewith central microdrusens (at risk of developing AMD) |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- General criteria for healthy volunteers and AMD patients:
- Specific criteria for the AMD group:
- General criteria for healthy volunteers:
- Specific criteria for the group of healthy volunteers with central microdrusens:
Key exclusion criteria (9 listed)
- Pregnant, parturient or breast-feeding women,
- Subjects taking medication likely to cause motor, visual, vestibular or cognitive disorders (PSA, neuroleptics, etc.) or who could interfere with the study examinations cannot be included in this study,
- Environmental opacity or eye movement disorders (nystagmus) which, in the opinion of the investigator, interfere with the quality of retinal imaging data.
- Any concomitant intraocular condition in the study eye (e.g. glaucoma or cataract) that, in the opinion of the investigator, would require surgical intervention during the study to prevent or treat vision loss that may result from this condition or affect the interpretation of study results,
- Known systemic disease which, in the opinion of the investigator, would preclude active participation 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 |
|---|---|---|
| patient-reported outcomePerformance of real-life tests and tasks | Other | 30 healthy volunteers, 30 healthy volunteers with central microdrusens (at risk of developing AMD), Patients with early-stage AMD, Patients with intermediate-stage AMD |
Primary outcome
Validity of criteria
Time frame: 26 month
Number of patients with capacity of discrimintaion compared to healthy volunteers. ROC (receiver operating characteristic curve), which illustrates the diagnostic capacity of a binary classification system as a function of the variation in its discrimination threshold. The ROC curve is created by plotting the rate of true positives versus the false-positive rate for different thresholds. The index used to characterize a test's of a test is the air under the curve
Validity of content
Time frame: 26 month
number of paticipants with capacity to execute questionnaires and daily real-life task
Reproducibility of results
Time frame: 26 month
Number of patients able to reproduce the same performance tests
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2024.
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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.
Michel PAQUES, Pr principal investigator
centre Hospitalier Nationald'Ophtalmologie
Questions about this trial
What is this clinical trial studying?
A study testing patient-reported outcome in people with Age-Related Macular Degeneration, run by Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts.
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 17 inclusion and 9 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: opening soon, as of the sponsor's last update on 27 Mar 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nabil BROUK (+33140021738, nbrouk@15-20.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validity of criteria (time frame: 26 month). The study lists 3 primary outcomes in all. 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 27 Mar 2024.