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

Hospital St. Joseph, Marseille, France88 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Diabetic Macular Edema

Interventions

telemedecine follow-upOTHER

weekly home-based follow-up of visual acuity on electronic tablet

Eligibility

Sex: ALLMin age: 25 Years

Medical Language ↔ Plain English

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.

Locations (1)

Hopital Saint Joseph Marseille

Marseille, France

Outcomes

Primary Outcomes

Rate of patients with VA evolution in the two groups

rate in percentage

Time frame: 36 months

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)

in days

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

the quality of life is assessed with EQ-5D-5L questionnaire

Time frame: 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.

Time frame: 36 months

Central Contacts

Cecile Bielmann

CONTACT

0033 (0)4 88 73 10 70 cbielmann@hopital-saint-joseph.fr

Data from ClinicalTrials.gov

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