Clinical trial

A Prospective Observational Study Conducted in France to Describe Routine Clinical Practice for Treatment naïve or Previously Treated Patients With Diabetic Macular Edema (DME) Who Are Starting IVT Aflibercept

Name

18636

Description

The main objectives of this observational study were to describe outcomes, monitoring and treatment patterns of patients with diabetic macular edema in routine clinical practice who are either treatment naïve patients or previously treated patients. The total study population was evaluated as well as the two subgroups (previously treated patients and treatment naïve patients). This study was designated to answer French Health Authority (HAS Haute Autorité de Santé) requirements.

Trial arms

Trial start

2016-09-21

Estimated PCD

2019-08-12

Trial end

2019-12-06

Status

Completed

Treatment

Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)

Eylea 40 mg/mL - recommended dose of 2 mg - intravitreal injection monthly for five consecutive months, which constitutes the loading dose. The loading dose is followed by one injection every two months. After 12 months of treatment, the interval between two injections can be prolonged or adapted according to visual and anatomical results.

Arms:

Entire study population, Naïve patient, Previously treated patient

Size

402

Primary endpoint

Mean change in Best Corrected Visual Acuity from baseline to month 12 in treatment naïve patients and previously treated patients

At baseline and 12 months

Eligibility criteria

Inclusion Criteria: * Man or woman aged 18 years or older * Patient diagnosed with a visual impairment due to diabetic macular disease (as defined by HAS (Haute Autorité de Santé) recommendation). * Patients in whom a decision to treat with intravitreal aflibercept has been made independently of the patient enrollment in the study * Patient diagnosed with type 1 or 2 diabetes mellitus * Patient who has been given appropriate information about the study and who has given his/her written, informed consent Exclusion Criteria: * Patient with other retinal disease at the time of inclusion * Patients currently being treated with intravitreal aflibercept. This study will only include patients new to intravitreal aflibercept * Systemic use of any anti / pro VEGF therapy (VEGF: Vascular Endothelial Growth Factor) * Patient taking part in an interventional study

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 402, 'type': 'ACTUAL'}}

Updated at

2023-11-07

1 organization

1 product

1 indication

Organization

Bayer

Product

Aflibercept

Indication

Diabetic Retinopathy