Age-related Macular DegenerationNCT04032808
Evaluation of the Performance of Self-monitoring Optimized by Therapeutic Education in the Recurrence of Wet Age-related Macular Degeneration (AMD)
An observational study of Age-related Macular Degeneration, run by Clinique Beau Soleil at 1 site in France.
Trial summary
Monocentric and prospective study, evaluating the benefit of self-monitoring optimized by therapeutic education either by the environmental Amsler or the Amsler grid according to the patient's choice and to determine the patient's ability to determine the reality itself recidivism and therefore the need for treatment. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Age-related Macular Degeneration
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- 10 Jul 2019to 10 Jul 2021
- 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 with AMD who have had at least one recurrence after a shared education assessment in which they have indicated the need or desire to participate in the control of their disease and who agree to participate in a therapeutic education program at the Beau Soleil Clinic
Who may be able to join
- Affiliation to a social security scheme
- Patient agreeing to participate in the process of therapeutic education.
- Centrofoveal fixation with visual acuity> 2/10
- Antecedent of at least one recurrence so that the patient is aware of the notion of recurrent chronic disease
- Intravitreal injection antecedent less than 6 months ago
Who cannot join
- Vulnerable people
- Majors subject to legal protection or unable to express their consent
- Arterial emboli disorders of less than three months such as myocardial infarction, stroke
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Clinique Beau Soleil
Montpellier, 34070
Sandy lacombe, 0467459397, s.lacombe@languedoc-mutualite.fr
Sophie Navarre, Dr
About this study
Monocentric and prospective study, evaluating the benefit of self-monitoring optimized by therapeutic education either by the environmental Amsler or the Amsler grid according to the patient's choice and to determine the patient's ability to determine the reality itself recidivism and therefore the need for treatment.
- Conditions
- Age-related Macular Degeneration
- Medical subject headings
- Macular Degeneration
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of self-monitoring by the environmental Amsler or the clinical Amsler grid according to the choice of the patient after therapeutic education.
Sensitivity and specificity of self-monitoring by the environmental Amsler or the clinical Amsler grid according to the choice of the patient after therapeutic education.
Measured: Through study completion, on average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2019
- Study start10 Jul 2019
- Primary completion10 Jul 2021 (estimated)
- Study completion10 Jul 2021 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinique Beau Soleil
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04032808
- Sponsor's protocol ID
- 2019-A00293-54
- Status last verified
- Feb 2021
- First submitted
- 22 Jul 2019
- Last updated
- 9 Feb 2021
- 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 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Performance of Self-monitoring Optimized by Therapeutic Education in the Recurrence of Wet Age-related Macular Degeneration (AMD)
- ClinicalTrials.gov ID
- NCT04032808
- Acronym / sponsor ID
- 2019-A00293-54
- Conditions
- Age-related Macular Degeneration
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Clinique Beau SoleilUniversity, hospital or other
- Study start
- 10 Jul 2019 (actual)
- Primary completion
- 10 Jul 2021 (estimated)
- Study completion
- 10 Jul 2021 (estimated)
- First posted
- 25 Jul 2019 (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.
Monocentric and prospective study, evaluating the benefit of self-monitoring optimized by therapeutic education either by the environmental Amsler or the Amsler grid according to the patient's choice and to determine the patient's ability to determine the reality itself recidivism and therefore the need for treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with AMD who have had at least one recurrence after a shared education assessment in which they have indicated the need or desire to participate in the control of their disease and who agree to participate in a therapeutic education program at the Beau Soleil Clinic
Key inclusion criteria (5 listed)
- Affiliation to a social security scheme
- Patient agreeing to participate in the process of therapeutic education.
- Centrofoveal fixation with visual acuity> 2/10
- Antecedent of at least one recurrence so that the patient is aware of the notion of recurrent chronic disease
- Intravitreal injection antecedent less than 6 months ago
Key exclusion criteria (3 listed)
- Vulnerable people
- Majors subject to legal protection or unable to express their consent
- Arterial emboli disorders of less than three months such as myocardial infarction, stroke
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sensitivity and specificity of self-monitoring by the environmental Amsler or the clinical Amsler grid according to the choice of the patient after therapeutic education.
Time frame: Through study completion, on average of 1 year
Sensitivity and specificity of self-monitoring by the environmental Amsler or the clinical Amsler grid according to the choice of the patient after therapeutic education.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2021.
Related trials for Age-related Macular Degeneration
RecruitingPhase 3
A Study of 36-Week Refill Exchanges of Port Delivery System (PDS) With Ranibizumab in nAMD
Neovascular Age-related Macular Degeneration
RecruitingObservational study
Pivotal Trial of an Automated AI-based System for Early Diagnosis and Prediction of Late Age-related Macular Degeneration
Age-related Macular Degeneration (AMD)
Active, not recruitingObservational study
Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
Active, not recruitingObservational study
Retinal Pigment Epithelium Safety Study For Patients In B4711001
Age Related Macular Degeneration
RecruitingObservational study
National Ophthalmic Genotyping and Phenotyping Network (eyeGENE (Registered Trademark)), Stage 3 - Expansion of DNA and Data Repositories for Rare Inherited Ophthalmic Diseases
Inherited Ophthalmic Diseases, Hypopigmentation Disorder
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.
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 Clinique Beau Soleil 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 5 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 9 Feb 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sandy Lacombe (0467459397, s.lacombe@languedoc-mutualite.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity of self-monitoring by the environmental Amsler or the clinical Amsler grid according to the choice of the patient after therapeutic education. (time frame: Through study completion, on average of 1 year). 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 9 Feb 2021.