NCT02581995

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

Open-label Phase-4 Study to Examine the Change of Vision-related Quality of Life in Subjects With Diabetic Macular Edema (DME) During Treatment With Intravitreal Injections of 2 mg Aflibercept According to EU Label for the First Year of Treatment

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 560 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Macular Edema

Interventions

Type	Name	Description
DRUG	Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)	2 mg aflibercept administered every 8 weeks following 5 initial monthly doses Intravitreal (IVT) injection

Timeline

• Start date: 2015-11-19
• Primary completion: 2017-08-09
• Completion: 2017-08-09
• First posted: 2015-10-21
• Last updated: 2018-10-10
• Results posted: 2018-10-10

Locations

76 sites across 14 countries: Austria, Canada, Czechia, France, Germany, Hungary, Italy, Lithuania, Poland, Portugal, Slovakia, Spain, Switzerland, United Kingdom

Regulatory

• FDA-regulated drug study