Age-related Macular Degeneration (AMD)DEMELENCT03690505
Assessment of the Knowledge and Needs of Patients With AMD Before a Therapeutic Patient Education Program is Put in Place
A study testing Interviews in people with Age-related Macular Degeneration (AMD), run by University Hospital, Limoges at 1 site in France.
Trial summary
Age-related macular degeneration (AMD) is a disease that blurs the sharp, central vision you need for "straight-ahead" activities such as reading, sewing, and driving. AMD affects the macula, the part of the eye that allows you to see fine detail The purpose of the study is to describe in patients with AMD and… Read more about this study
- Who is it for?
- Ages 50 months and older
- Conditions the study is for
- Age-related Macular Degeneration (AMD)
- What is being tested?
- Interviews
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteFrance
- Study dates
- 12 Mar 2019to 4 Jan 2023
- 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 50 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient with AMD (neovascular and atrophic) whatever the stage of the disease
- Patient over 50
- Patient affiliated to a social security scheme
- Written informed consent of the patient
Who cannot join
- Patient unable to understand the information, fill out the questionnaires
- Patient with diabetic retinopathy
Trial locations and contacts
1 site in 1 country.
About this study
Age-related macular degeneration (AMD) is a disease that blurs the sharp, central vision you need for "straight-ahead" activities such as reading, sewing, and driving. AMD affects the macula, the part of the eye that allows you to see fine detail
The purpose of the study is to describe in patients with AMD and depending on the nature of their pathology (neovascular or atrophic):
Read more
(i) knowledge about their pathology (risk factors, symptoms, treatments, self-monitoring tool), (ii) their needs and (iii) impact on their daily lives
This study is to make an inventory of the knowledge of patients with AMD about their disease and risk factors using a questionnaire (Appendix 1) and to identify their needs, the impact of the disease on their daily lives during individual interviews by raising the recurrent data and confronting them during the focus group. The information gathered will enable the construction of a therapeutic education program for better patient care and to strengthen the patient's capacities so that he becomes an actor in his change throughout his care project.
This a 3 steps study:
- 200 patients will be enrolled and answer a questionnaire on knowledge of the disease
- Two groups of 20 patients will be selected to participate to a semi-structured individual interviews
- Two focus groups of 10 patients will be organized to assess needs, expectations, satisfactions or to better understand opinions, motivations or behaviors.
- Conditions
- Age-related Macular Degeneration (AMD)
- Being tested
- Interviews
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterviewsBehavioural
informant-based questionnaire semi-structured individual interviews focus group interviews
| Study group | Role | What they receive |
|---|---|---|
| Assessment | Other | Assessment of the Knowledge and Needs of Patients With AMD Before a Therapeutic Patient Education Program is Put in Place Receives: Behavioral: Interviews |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge of AMD
Assesment concern patients knowledge of AMD disease, the treatment of AMD, the diagnostic of AMD and the knowledge on the AMD risk factors A 12 items standardised questionnaire will be used
Measured: throughout the study, 2 years at maximum
Social vulnerability
Assessed by EPICES scale (Evaluation of Precariousness and Health Inequalities in the Health Examination Centers). It is an individual indicator of precariousness that takes into account the multidimensional nature of precariousness. Compsed of 11 items . 4 unfavorable answers indicate a Social vulnerability
Measured: throughout the study, 2 years at maximum
Secondary outcomes (1)
Health literacy.
Assessed by the Health Literacy Questionnaire (HLQ) scale. It has nine scales that each measure an aspect of the multidimensional construct of health literacy.
Higher scores assess for an good health literacy
Measured: throughout the study, 2 years at maximum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2018
- Study start12 Mar 2019
- Primary completion16 May 2019
- Study completion4 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-related Macular Degeneration (AMD)Studies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03690505
- Sponsor's protocol ID
- I16027/DEMELE
- Acronym
- DEMELE
- Status last verified
- Jun 2026
- First submitted
- 13 Sep 2018
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Knowledge and Needs of Patients With AMD Before a Therapeutic Patient Education Program is Put in Place
- ClinicalTrials.gov ID
- NCT03690505
- Acronym / sponsor ID
- DEMELE / I16027/DEMELE
- Conditions
- Age-related Macular Degeneration (AMD)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- 12 Mar 2019 (actual)
- Primary completion
- 16 May 2019 (actual)
- Study completion
- 4 Jan 2023 (actual)
- First posted
- 1 Oct 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.
Age-related macular degeneration (AMD) is a disease that blurs the sharp, central vision you need for "straight-ahead" activities such as reading, sewing, and driving. AMD affects the macula, the part of the eye that allows you to see fine detail
The purpose of the study is to describe in patients with AMD and depending on the nature of their pathology (neovascular or atrophic):
(i) knowledge about their pathology (risk factors, symptoms, treatments, self-monitoring tool), (ii) their needs and (iii) impact on their daily lives
This study is to make an inventory of the knowledge of patients with AMD about their disease and risk factors using a questionnaire (Appendix 1) and to identify their needs, the impact of the disease on their daily lives during individual interviews by raising the recurrent data and confronting them during the focus group. The information gathered will enable the construction of a therapeutic education program for better patient care and to strengthen the patient's capacities so that he becomes an actor in his change throughout his care project.
This a 3 steps study:
- 200 patients will be enrolled and answer a questionnaire on knowledge of the disease
- Two groups of 20 patients will be selected to participate to a semi-structured individual interviews
- Two focus groups of 10 patients will be organized to assess needs, expectations, satisfactions or to better understand opinions, motivations or behaviors.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Assessment | Other | Behavioral: InterviewsAssessment of the Knowledge and Needs of Patients With AMD Before a Therapeutic Patient Education Program is Put in Place |
Who may qualify
- Ages
- 50 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patient with AMD (neovascular and atrophic) whatever the stage of the disease
- Patient over 50
- Patient affiliated to a social security scheme
- Written informed consent of the patient
Key exclusion criteria (2 listed)
- Patient unable to understand the information, fill out the questionnaires
- Patient with diabetic retinopathy
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 |
|---|---|---|
| Interviewsinformant-based questionnaire semi-structured individual interviews focus group interviews | Behavioural | Assessment |
Primary outcome
Knowledge of AMD
Time frame: throughout the study, 2 years at maximum
Assesment concern patients knowledge of AMD disease, the treatment of AMD, the diagnostic of AMD and the knowledge on the AMD risk factors A 12 items standardised questionnaire will be used
Social vulnerability
Time frame: throughout the study, 2 years at maximum
Assessed by EPICES scale (Evaluation of Precariousness and Health Inequalities in the Health Examination Centers). It is an individual indicator of precariousness that takes into account the multidimensional nature of precariousness. Compsed of 11 items . 4 unfavorable answers indicate a Social vulnerability
1 secondary outcome
Health literacy.
Time frame: throughout the study, 2 years at maximum
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 Jun 2026.
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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?
A study testing Interviews in people with Age-related Macular Degeneration (AMD), run by University Hospital, Limoges 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 2 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 Jun 2026. 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?
Knowledge of AMD (time frame: throughout the study, 2 years at maximum). The study lists 2 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 24 Jun 2026.