At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 560 enrolled
Drug / intervention
Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)drug
Likely dose
Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321) 2 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 4 clinical trial evaluating Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321) for Macular Edema. Completed, enrolled 560 participants across 76 sites in 14 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMacular Edema
CountriesAustria, Canada, Czechia, France, Germany, Hungary, Italy, Lithuania, Poland, Portugal, Slovakia, Spain, Switzerland, United Kingdom
Collaborators--
Timeline
Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedOct 2015
Enrollment StartNov 2015
Primary CompletionAug 2017
TodayJul 2026
First PostedOct 21, 2015
Enrollment StartNov 19, 2015
Primary CompletionAug 9, 2017
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 10.7 years ago
Interventions
Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)drug
2 mg aflibercept administered every 8 weeks following 5 initial monthly doses Intravitreal (IVT) injection