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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

Primary Purpose

Diabetic Macular Edema

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
telemedecine follow-up
Sponsored by
Hospital St. Joseph, Marseille, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Diabetic Macular Edema

Eligibility Criteria

25 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hopital Saint Joseph Marseille

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Telemedecine follow-up

Hospital follow-up

Arm Description

Outcomes

Primary Outcome Measures

Rate of patients with VA evolution in the two groups
rate in percentage

Secondary Outcome Measures

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

Full Information

First Posted
February 25, 2021
Last Updated
February 25, 2021
Sponsor
Hospital St. Joseph, Marseille, France
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1. Study Identification

Unique Protocol Identification Number
NCT04776343
Brief Title
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
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 2021 (Anticipated)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital St. Joseph, Marseille, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Macular Edema

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
88 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Telemedecine follow-up
Arm Type
Experimental
Arm Title
Hospital follow-up
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
telemedecine follow-up
Intervention Description
weekly home-based follow-up of visual acuity on electronic tablet
Primary Outcome Measure Information:
Title
Rate of patients with VA evolution in the two groups
Description
rate in percentage
Time Frame
36 months
Secondary Outcome Measure Information:
Title
Variation of the VA measured using ETDRS scale on TC for the patients followed at home
Time Frame
36 months
Title
Variation of the VA measured using ETDRS scale on TC for the patients followed at the hospital
Time Frame
36 months
Title
Number of follow-up and injection visits for each patient according to their group
Time Frame
36 months
Title
Average time between the follow-up visit and the IVT (if performed)
Description
in days
Time Frame
36 months
Title
Variations in foveolar thickness and maximum central retinal thickness on OCT
Time Frame
36 months
Title
Change in quality of life for patients in group 1 compared to group 2
Description
the quality of life is assessed with EQ-5D-5L questionnaire
Time Frame
36 months
Title
Change in the total cost per patient for patient in group 1 compared to group 2.
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cecile Bielmann
Phone
0033 (0)4 88 73 10 70
Email
cbielmann@hopital-saint-joseph.fr
Facility Information:
Facility Name
Hopital Saint Joseph Marseille
City
Marseille
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cécile Bielmann
First Name & Middle Initial & Last Name & Degree
Frédéric Queguiner

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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