NCT01512966

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
73

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2012

Geographic Reach
1 country

18 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

January 16, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 20, 2012

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

October 9, 2014

Status Verified

October 1, 2014

Enrollment Period

1.7 years

First QC Date

January 16, 2012

Last Update Submit

October 8, 2014

Conditions

Macular Edema

Keywords

Diabetic Macular EdemaDMEVEGF Trap-Eyebest-corrected visual acuity (BCVA)

Outcome Measures

Primary Outcomes (1)

  • Adverse Event collection

    Week 52

Secondary Outcomes (1)

  • Change from baseline in BCVA (best corrected visual acuity) letter score

    Week 52

Study Arms (1)

VTE 2Q4 first, then VTE 2Q8

EXPERIMENTAL

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)

Biological: VEGF Trap-Eye (BAY86-5321)

Interventions

VEGF Trap-Eye (BAY86-5321)BIOLOGICAL

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.

VTE 2Q4 first, then VTE 2Q8

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

Unknown Facility

Matsuyama, Ehime, 790-8524, Japan

Location

Unknown Facility

Maebashi, Gunma, 371-8511, Japan

Location

Unknown Facility

Kobe, Hyōgo, 650-0017, Japan

Location

Unknown Facility

Mito, Ibaraki, 310-0015, Japan

Location

Unknown Facility

Kita, Kagawa-ken, 761-0793, Japan

Location

Unknown Facility

Kagoshima, Kagoshima-ken, 890-8520, Japan

Location

Unknown Facility

Kawasaki, Kanagawa, 216-8511, Japan

Location

Unknown Facility

Kyoto, Kyoto, 606-8507, Japan

Location

Unknown Facility

Sendai, Miyagi, 984-8560, Japan

Location

Unknown Facility

Kashihara, Nara, 634-8522, Japan

Location

Unknown Facility

Okayama, Okayama-ken, 700-8558, Japan

Location

Unknown Facility

Osaka, Osaka, 537-0025, Japan

Location

Unknown Facility

Osaka, Osaka, 558-8558, Japan

Location

Unknown Facility

Suita, Osaka, 565-0871, Japan

Location

Unknown Facility

Saga, Saga-ken, 840-8571, Japan

Location

Unknown Facility

Ōtsu, Shiga, 520-2192, Japan

Location

Unknown Facility

Shimotsuke, Tochigi, 329-0498, Japan

Location

Unknown Facility

Wakayama, Wakayama, 641-8510, Japan

Location

MeSH Terms

Conditions

Macular Edema

Interventions

aflibercept

Condition Hierarchy (Ancestors)

Macular DegenerationRetinal DegenerationRetinal DiseasesEye Diseases

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2012

First Posted

January 20, 2012

Study Start

January 1, 2012

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

October 9, 2014

Record last verified: 2014-10

Locations

JP(18)