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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Diabetic Macular Edema

Intervention / Treatment
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* Other: telemedecine follow-up


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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; having an internet access at home; having given free and informed written consent; being affiliated with or benefiting from a social security scheme. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telemedecine follow-up<br> | Other: telemedecine follow-up<br>* weekly home-based follow-up of visual acuity on electronic tablet<br>|
| No Intervention: Hospital follow-up<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of patients with VA evolution in the two groups | rate in percentage | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variation of the VA measured using ETDRS scale on TC for the patients followed at home |  | 36 months | 
| Variation of the VA measured using ETDRS scale on TC for the patients followed at the hospital |  | 36 months | 
| Number of follow-up and injection visits for each patient according to their group |  | 36 months | 
| Average time between the follow-up visit and the IVT (if performed) | in days | 36 months | 
| Variations in foveolar thickness and maximum central retinal thickness on OCT |  | 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 | 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. | 36 months |