Overview

This trial is active, not recruiting.

Conditions diabetes mellitus, macular edema
Treatments vegf trap-eye (bay86-5321), laser treatment
Phase phase 3
Sponsor Bayer
Collaborator Regeneron Pharmaceuticals
Start date May 2011
End date June 2013
Trial size 404 participants
Trial identifier NCT01331681, 2010-022364-12, 91745

Summary

To determine the efficacy of intravitreally (IVT) administered VEGF Trap-Eye on the best-corrected visual acuity (BCVA) assessed by the early treatment diabetic retinopathy study (ETDRS) chart in subjects with diabetic macular edema (DME) with central involvement

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
vegf trap-eye (bay86-5321)
VEGF Trap-Eye Regimen 1
(Experimental)
vegf trap-eye (bay86-5321)
VEGF Trap-Eye Regimen 2
(Active Comparator)
laser treatment
Macular laser photocoagulation using modified ETDRS protocol

Primary Outcomes

Measure
Change from baseline of BCVA in ETDRS letter score
time frame: Week 52

Secondary Outcomes

Measure
Change in retinal thickness from baseline
time frame: Week 52
Change in quality of life questionnaire subscale 1 from Baseline
time frame: Week 52
Change in quality of life questionnaire subscale 2 from Baseline
time frame: Week 52
Proportion of subjects who gain threshold 1 change from baseline in visual acuity
time frame: Week 52
Proportion of subjects who gain threshold 2 change from baseline in visual acuity
time frame: Week 52
Proportion of subjects who gain a threshold change from baseline in the diabetic retinopathy severity score
time frame: Week 52

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Adults ≥ 18 years with type 1 or 2 diabetes mellitus - Subjects with DME secondary to diabetes mellitus involving the center of the macula in the study eye - Decrease in vision determined to be primarily the result of DME in the study eye - BCVA ETDRS letter score of 73 to 24 (20/40 to 20/320) in the study eye Exclusion Criteria: - Laser photocoagulation (panretinal or macular) in the study eye within 90 days of Day 1 - More than 2 previous macular laser treatments in the study eye - Previous use of intraocular or periocular corticosteroids in the study eye within 120 days of Day 1 - Previous treatment with antiangiogenic drugs in either eye (pegaptanib sodium, bevacizumab, ranibizumab etc.) within 90 days of Day 1 - Active proliferative diabetic retinopathie (PDR) in the study eye, with the exception of inactive, regressed PDR - Uncontrolled diabetes mellitus, as defined by HbA1c > 12% - Only 1 functional eye even if that eye is otherwise eligible for the study

Additional Information

Official title A Randomized, Double Masked, Active Controlled, Phase III Study of the Efficacy and Safety of Repeated Doses of Intravitreal VEGF Trap-Eye in Subjects With Diabetic Macular Edema
Trial information was received from ClinicalTrials.gov and was last updated in May 2014.
Information provided to ClinicalTrials.gov by Bayer.