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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Diabetic Macular Edema
• Intervention / Treatment: Other: telemedecine follow-up

• Study Type: Interventional
• Enrollment (Anticipated): 88
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cécile Bielmann; Phone Number: 0033 (0)4 88 73 10 70; Email: cbielmann@hopital-saint-joseph.fr

Study Locations

• France
  • Marseille, France
    • Hôpital Saint Joseph Marseille
    • Principal Investigator: Frédéric Queguiner

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hospital St. Joseph, Marseille, France

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2021
• Primary Completion (Anticipated): April 1, 2024
• Study Completion (Anticipated): April 1, 2024

Study Registration Dates

• First Submitted: February 25, 2021
• First Submitted That Met QC Criteria: February 25, 2021
• First Posted (Actual): March 1, 2021

Study Record Updates

• Last Update Posted (Actual): March 1, 2021
• Last Update Submitted That Met QC Criteria: February 25, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Macular Edema; Edema
• Other Study ID Numbers: 2020_06_02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No