Diabetic Macular EdemaNCT04776343
Study Comparing Two Populations of Patients Treated With Anti VEGF for Diabetic Macular Edema, One Being Followed at the Hospital and the Other One Being Followed at Home Using a Software Allowing Self-assessment of Visual Acuity
A study testing telemedecine follow-up in people with Diabetic Macular Edema, run by Hospital St. Joseph, Marseille, France at 1 site in France.
Trial summary
Verify the reliability of VA measured every week at home, by the patient using a TC, compared to the reliability of VA also measured by the patient using a TC but every 2 month at the hospital, during standard DME follow-up visits Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- Diabetic Macular Edema
- What is being tested?
- telemedecine follow-up
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2021to Apr 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 25 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Will be included in the study, patients with all of the following criteria:
- aged ≥ 25 years old (the minimum age is set at 25 years old in order to include patient with controlled diabetes);
- diagnosed with DME;
- followed and treated by anti-VEGF IVT in the ophthalmology debarment at Hopital Saint Joseph Marseille;
- having a VA score ≥ 20/100;
- able to understand the study and to use a TC;
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- having an internet access at home;
- having given free and informed written consent;
- being affiliated with or benefiting from a social security scheme.
Who cannot join
- Will not be included in the study, patients with one of the following criteria:
- treated for another pathology that DME;
- already participating to another research study;
- pregnant or breastfeeding woman;
- subject to a measure for the protection of justice.
Trial locations and contacts
1 site in 1 country.
France1 site
Hopital Saint Joseph Marseille
Marseille
Cécile Bielmann
Frédéric Queguiner
About this study
Official title: Prospective, Randomized Study Comparing Two Populations of Patients Treated With Anti VEGF for Diabetic Macular Edema, One Being Followed at the Hospital and the Other One Being Followed at Home Using a Software Allowing Self-assessment of Visual Acuity
Verify the reliability of VA measured every week at home, by the patient using a TC, compared to the reliability of VA also measured by the patient using a TC but every 2 month at the hospital, during standard DME follow-up visits
- Conditions
- Diabetic Macular Edema
- Being tested
- telemedecine follow-up
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
telemedecine follow-upOther
weekly home-based follow-up of visual acuity on electronic tablet
| Study group | Role | What they receive |
|---|---|---|
| Telemedecine follow-up | Experimental | Not described Receives: Other: telemedecine follow-up |
| Hospital follow-up | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of patients with VA evolution in the two groups
rate in percentage
Measured: 36 months
Secondary outcomes (7)
Variation of the VA measured using ETDRS scale on TC for the patients followed at home
Measured: 36 months
Variation of the VA measured using ETDRS scale on TC for the patients followed at the hospital
Measured: 36 months
Number of follow-up and injection visits for each patient according to their group
Measured: 36 months
Average time between the follow-up visit and the IVT (if performed)
in days
Measured: 36 months
Variations in foveolar thickness and maximum central retinal thickness on OCT
Measured: 36 months
Change in quality of life for patients in group 1 compared to group 2
the quality of life is assessed with EQ-5D-5L questionnaire
Measured: 36 months
Change in the total cost per patient for patient in group 1 compared to group 2.
The total cost per patient is calculated from the number of follow-up visits, the number of procedures (OCT and fundus retinography) and the number of IVTs.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2021
- Study startApr 2021 (estimated)
- Primary completionApr 2024 (estimated)
- Study completionApr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Macular EdemaStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital St. Joseph, Marseille, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04776343
- Sponsor's protocol ID
- 2020_06_02
- Status last verified
- Feb 2021
- First submitted
- 25 Feb 2021
- Last updated
- 1 Mar 2021
- Results posted
- 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 1 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized Study Comparing Two Populations of Patients Treated With Anti VEGF for Diabetic Macular Edema, One Being Followed at the Hospital and the Other One Being Followed at Home Using a Software Allowing Self-assessment of Visual Acuity
- ClinicalTrials.gov ID
- NCT04776343
- Acronym / sponsor ID
- 2020_06_02
- Conditions
- Diabetic Macular Edema
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Hospital St. Joseph, Marseille, FranceUniversity, hospital or other
- Study start
- Apr 2021 (estimated)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 1 Mar 2021 (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.
Verify the reliability of VA measured every week at home, by the patient using a TC, compared to the reliability of VA also measured by the patient using a TC but every 2 month at the hospital, during standard DME follow-up visits
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telemedecine follow-up | Experimental | Other: telemedecine follow-up |
| Hospital follow-up | No intervention | – |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- aged ≥ 25 years old (the minimum age is set at 25 years old in order to include patient with controlled diabetes);
- diagnosed with DME;
- followed and treated by anti-VEGF IVT in the ophthalmology debarment at Hopital Saint Joseph Marseille;
- having a VA score ≥ 20/100;
- able to understand the study and to use a TC;
Key exclusion criteria (5 listed)
- treated for another pathology that DME;
- already participating to another research study;
- pregnant or breastfeeding woman;
- subject to a measure for the protection of justice.
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 |
|---|---|---|
| telemedecine follow-upweekly home-based follow-up of visual acuity on electronic tablet | Other | Telemedecine follow-up |
Primary outcome
Rate of patients with VA evolution in the two groups
Time frame: 36 months
rate in percentage
7 secondary outcomes
Variation of the VA measured using ETDRS scale on TC for the patients followed at home
Time frame: 36 months
Variation of the VA measured using ETDRS scale on TC for the patients followed at the hospital
Time frame: 36 months
Number of follow-up and injection visits for each patient according to their group
Time frame: 36 months
Average time between the follow-up visit and the IVT (if performed)
Time frame: 36 months
Variations in foveolar thickness and maximum central retinal thickness on OCT
Time frame: 36 months
Change in quality of life for patients in group 1 compared to group 2
Time frame: 36 months
Change in the total cost per patient for patient in group 1 compared to group 2.
Time frame: 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2021.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing telemedecine follow-up in people with Diabetic Macular Edema, run by Hospital St. Joseph, Marseille, France 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 9 inclusion and 5 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 1 Mar 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 Cecile Bielmann (0033 (0)4 88 73 10 70, cbielmann@hopital-saint-joseph.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of patients with VA evolution in the two groups (time frame: 36 months). 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 1 Mar 2021.