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

Bayer

Status and phase: Completed; Phase 3

Conditions: Macular Edema

Treatments: Biological: VEGF Trap-Eye (BAY86-5321)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01512966

15657

Details and patient eligibility

About

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.

Enrollment: 73 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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73 participants in 1 patient group

VTE 2Q4 first, then VTE 2Q8

Experimental group

Description:

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)

Treatment:

Biological: VEGF Trap-Eye (BAY86-5321)