Routine Clinical Practice for Use of Intravitreal Aflibercept Treatment in Patients With Diabetic Macular Edema

Bayer402 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

402

Conditions

Diabetic Retinopathy

Interventions

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

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Multiple Locations, France

Outcomes

Primary Outcomes

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

Time frame: At baseline and 12 months

Secondary Outcomes

Mean change in Best Corrected Visual Acuity between baseline and 12-month follow-up for the entire study population

Time frame: At baseline and 12 months

Mean change in Best Corrected Visual Acuity between baseline and 24-month follow-up for all groups

Time frame: At baseline and 24 months

Mean change in Central Retinal Thickness between baseline and 12-month follow-up for all groups

Time frame: At baseline and 12 months

Mean change in Central Retinal Thickness between baseline visit and 24-month follow-up for all groups

Time frame: At baseline and 24 months

Type of the previous treatment(s) in previously treated patients

i.e: photocoagulation laser therapy, anti-VEGF treatment, intraocular steroids

Time frame: At baseline

Duration (months) of the previous treatment in previously treated patients

Time frame: At baseline

Date of the last administered treatment in previously treated patients

Time frame: At baseline

Reason for starting intravitreal aflibercept

i.e: clinically significant macular edema conducting to a decrease of visual acuity, early care of DME, laser photocoagulation or vitrectomy not indicated, diabetes care not optimized

Data from ClinicalTrials.gov

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