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

• Status: Completed
• Trial end date: 2017-08-09
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Treatments: Aflibercept

Criteria

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