Investigation of the Change of Vision-related Quality of Life in Subjects Treated With Aflibercept According to EU Label for DME.
- Sponsor
- Bayer
- Study ID
- NCT02581995
- Phase
- PHASE4
- Status
- Completed
Conditions
- Macular Edema
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321) — DRUG2 mg aflibercept administered every 8 weeks following 5 initial monthly doses Intravitreal (IVT) injection
Study Details
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.
Key Dates
- Start date
- Nov 19, 2015
- Status verified
- Sep 2018
- Primary completion
- Aug 9, 2017
- Completion
- Aug 9, 2017
Study Design
- Enrollment
- 560 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Arm 1 / Quality of LifeAflibercept treatment in subjects with diabetic macular edema (DME)
Primary Outcome Measure
Change From Baseline to Week 52 in NEI VFQ-25 Total Score [ Time Frame: Baseline, Week 52 ]
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