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

Diabetic Macular Edema Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04776343
• Other study ID #: 2020_06_02
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2021
• Est. completion date: April 2024

Study information

• Verified date: February 2021
• Source: Hospital St. Joseph, Marseille, France
• Contact: Cecile Bielmann
• Phone: 0033 (0)4 88 73 10 70
• Email: cbielmann[@]hopital-saint-joseph.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 88
• Est. completion date: April 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Edema
• Macular Edema

Intervention

Other:
• telemedecine follow-up
weekly home-based follow-up of visual acuity on electronic tablet

Locations

Country	Name	City	State
France	Hopital Saint Joseph Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Hospital St. Joseph, Marseille, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of patients with VA evolution in the two groups	rate in percentage	36 months
Secondary	Variation of the VA measured using ETDRS scale on TC for the patients followed at home		36 months
Secondary	Variation of the VA measured using ETDRS scale on TC for the patients followed at the hospital		36 months
Secondary	Number of follow-up and injection visits for each patient according to their group		36 months
Secondary	Average time between the follow-up visit and the IVT (if performed)	in days	36 months
Secondary	Variations in foveolar thickness and maximum central retinal thickness on OCT		36 months
Secondary	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
Secondary	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