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

NCT02581995 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 560

Last updated 2018-10-10

Study results available
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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

DRUG

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

2 mg aflibercept administered every 8 weeks following 5 initial monthly doses Intravitreal (IVT) injection

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-19
Primary Completion
2017-08-09
Completion
2017-08-09
FDA Drug
Yes

Countries

  • Austria
  • Canada
  • Czechia
  • France
  • Germany
  • Hungary
  • Italy
  • Lithuania
  • Poland
  • Portugal
  • Slovakia
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02581995 on ClinicalTrials.gov