---
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
nct_id: NCT04776343
overall_status: UNKNOWN
phase: NA
sponsor: Hospital St. Joseph, Marseille, France
study_type: INTERVENTIONAL
primary_condition: Diabetic Macular Edema
countries: France
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04776343.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04776343"
ct_last_update_post_date: 2021-03-01
last_seen_at: "2026-05-12T07:34:25.685Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# 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

**NCT ID:** [NCT04776343](https://clinicaltrials.gov/study/NCT04776343)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 88
- **Lead Sponsor:** Hospital St. Joseph, Marseille, France
- **Conditions:** Diabetic Macular Edema
- **Start Date:** 2021-04
- **Completion Date:** 2024-04
- **CT.gov Last Update:** 2021-03-01

## 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

## Eligibility

- **Minimum age:** 25 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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.
```

## Arms

- **Telemedecine follow-up** (EXPERIMENTAL)
- **Hospital follow-up** (NO_INTERVENTION)

## Interventions

- **telemedecine follow-up** (OTHER) — weekly home-based follow-up of visual acuity on electronic tablet

## Primary Outcomes

- **Rate of patients with VA evolution in the two groups** _(time frame: 36 months)_ — rate in percentage

## 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)** _(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** _(time frame: 36 months)_
- **Change in the total cost per patient for patient in group 1 compared to group 2.** _(time frame: 36 months)_

## Locations (1)

- Hopital Saint Joseph Marseille, Marseille, France

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.hopital saint joseph marseille|marseille||france` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT04776343.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT04776343*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*