Overview

This trial is active, not recruiting.

Condition macular edema
Treatment eylea (aflibercept, vegf trap-eye, bay86-5321)
Phase phase 4
Sponsor Bayer
Start date November 2015
End date August 2017
Trial size 477 participants
Trial identifier NCT02581995, 17850

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Aflibercept treatment in subjects with diabetic macular edema (DME)
eylea (aflibercept, vegf trap-eye, bay86-5321)
2 mg aflibercept administered every 8 weeks following 5 initial monthly doses Intravitreal (IVT) injection

Primary Outcomes

Measure
Change from baseline to week 52 in NEI VFQ 25 total score
time frame: Baseline and 52 weeks

Secondary Outcomes

Measure
Change from baseline to week 52 in the NEI VFQ-25 near activities subscale
time frame: Baseline and 52 weeks
Change from baseline to week 52 in the NEI VFQ-25 distant activities subscale
time frame: Baseline and 52 weeks
Change from baseline to week 52 in best corrected visual acuity (BCVA)
time frame: Baseline and 52 weeks
Change from baseline to week 52 in central retinal thickness (CRT) measured by optical coherence tomography (OCT)
time frame: Baseline and 52 weeks
Proportion of subjects progressing to ≥ 61 ETDRS diabetic retinopathy severity scale (DRSS) as assessed by fundus photography (FP)
time frame: up to 52 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title 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
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Bayer.