Japanese Safety Study of VEGF Trap-Eye in DME (Diabetic Macular Edema)

Phase 3

Completed

• Conditions: Macular Edema
• Interventions: Biological: VEGF Trap-Eye (BAY86-5321)

• Registration Number: NCT01512966
• Lead Sponsor: Bayer

Brief Summary

This study will assess the safety and tolerability of intravitreally (IVT) administered VEGF Trap-Eye in Japanese subjects with diabetic macular edema (DME) over the period of one year.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-01-16
• Study First Submitted QC: 2012-01-16
• Study First Posted: 2012-01-20
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-08
• Last Update Posted: 2014-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

Inclusion Criteria

• Adults ≥ 18 years with type 1 or 2 diabetes mellitus
• Subjects with DME (diabetic macular edema) secondary to diabetes mellitus involving the center of the macula in the study eye
• BCVA (best-corrected visual acuity) ETDRS (Early Treatment Diabetic Retinopathy Study) letter score of 73 to 24 (20/40 to 20/320) in the study eye

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Exclusion Criteria

• Active proliferative diabetic retinopathy (PDR) in the study eye
• Uncontrolled diabetes mellitus, as defined by HbA1c >12%
• Only 1 functional eye even if that eye is otherwise eligible for the study

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
VTE 2Q4 first, then VTE 2Q8	VEGF Trap-Eye (BAY86-5321)	VEGF Trap-Eye \[BAY86-5321; EYLEA (aflibercept) Injection\] 2 mg Q4 (VTE 2Q4) administered every 4 weeks from Week 0 to Week 16, followed by every 8 weeks until Week 48 (2Q8)

Primary Outcome Measures

Name	Time	Method
Adverse Event collection	Week 52

Secondary Outcome Measures

Name	Time	Method
Change from baseline in BCVA (best corrected visual acuity) letter score	Week 52