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

Bayer

Status: Completed

Conditions: Diabetic Retinopathy

Treatments: Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)

Study type: Observational

Funder types: Industry

Identifiers

NCT02924311

18636

Details and patient eligibility

About

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.

Enrollment: 402 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

402 participants in 3 patient groups

Previously treated patient

Description:

Already treated with any other treatment such as an anti-VEGF agent (other than IVT aflibercept), macular laser photocoagulation (laser), intravitreal steroid injection or implant (steroids) and initiating treatment with IVT aflibercept

Treatment:

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

Naïve patient

Description:

Not previously treated with an anti-VEGF agent, macular laser photocoagulation (laser) or intravitreal steroid injection or implant (steroids) and initiating treatment with IVT aflibercept

Treatment:

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

Entire study population

Description:

Already treated patient with any other treatment such as an anti-VEGF agent (other than intravitreal aflibercept), macular laser photocoagulation, intravitreal steroid injection and initiating treatment with intravitreal aflibercept and not previously treated patients with an anti-VEGF agent, macular laser photocoagulation or intravitreal steroids injection and initiating treatment with intravitreal aflibercept

Treatment:

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