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

NCT04776343 | Unknown

• 1 other identifier: 2020_06_02
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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

Conditions

Diabetic Macular Edema

Outcome Measures

Primary Outcomes (1)

• Rate of patients with VA evolution in the two groups

  rate in percentage

  36 months

Secondary Outcomes (7)

• 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)

  36 months

• Variations in foveolar thickness and maximum central retinal thickness on OCT

  36 months

Study Arms (2)

Telemedecine follow-up

EXPERIMENTAL

Other: telemedecine follow-up

Hospital follow-up

NO INTERVENTION

Interventions

telemedecine follow-up OTHER

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

Telemedecine follow-up

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital St. Joseph, Marseille, France: lead

Study Sites (1)

Hopital Saint Joseph Marseille

Marseille, France

Location

Central Study Contacts

Cecile Bielmann

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2021
• First Posted: March 1, 2021
• Study Start: April 1, 2021
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: March 1, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)