Investigation of the Change of Vision-related Quality of Life in Subjects Treated With Aflibercept According to EU Label for DME. (AQUA)

Bayer

Status and phase: Completed; Phase 4

Conditions: Macular Edema

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT02581995

17850

2014-005119-17 (EudraCT Number)

Details and patient eligibility

About

To evaluate the change in quality of life (NEI VFQ 25) in subjects with DME during the first year of treatment with aflibercept according to the EU Label.

Enrollment: 560 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 1 or 2 diabetes mellitus
• Diagnosis of DME secondary to diabetes mellitus involving the center of the macula (defined as the area of the center subfield on OCT) in the study eye
• Decrease in vision determined to be primarily the result of DME in the study eye
• BCVA in the study eye of ETDRS letter score 73 to 24 (This corresponds to a Snellen equivalent of approximately 20/40 to 20/320.)

Exclusion criteria

• Pregnancy and lactation
• Mismatch with inclusion criteria

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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560 participants in 1 patient group

Arm 1 / Quality of Life

Experimental group

Description:

Aflibercept treatment in subjects with diabetic macular edema (DME)

Treatment:

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