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

An Open-label Phase III Study Evaluating the Safety and Tolerability of Repeated Doses of Intravitreal VEGF Trap-Eye in Japanese Subjects With Diabetic Macular Edema

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01512966

Acronym

VIVID-Japan

Enrollment

Registered

2012-01-20

Start date

2012-01-31

Completion date

2013-09-30

Last updated

2014-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Macular Edema

Keywords

Diabetic Macular Edema, DME, VEGF Trap-Eye, best-corrected visual acuity (BCVA)

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.

Interventions

BIOLOGICALVEGF Trap-Eye (BAY86-5321)

Subjects in the VEGF Trap-Eye group will receive intravitreal injections every 8 weeks following a loading phase with injections given every 4 weeks. The overall treatment period is 48 weeks.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Adverse Event collection	Week 52

Secondary

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

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026