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

October 8, 2014 updated by: Bayer

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

73

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Kagoshima, Japan, 890-8520
      • Kyoto, Japan, 606-8507
      • Okayama, Japan, 700-8558
      • Osaka, Japan, 558-8558
      • Osaka, Japan, 537-0025
      • Saga, Japan, 840-8571
      • Wakayama, Japan, 641-8510
    • Ehime
      • Matsuyama, Ehime, Japan, 790-8524
    • Gunma
      • Maebashi, Gunma, Japan, 371-8511
    • Hyogo
      • Kobe, Hyogo, Japan, 650-0017
    • Ibaraki
      • Mito, Ibaraki, Japan, 310-0015
    • Kagawa
      • Kita, Kagawa, Japan, 761-0793
    • Kanagawa
      • Kawasaki, Kanagawa, Japan, 216-8511
    • Miyagi
      • Sendai, Miyagi, Japan, 984-8560
    • Nara
      • Kashihara, Nara, Japan, 634-8522
    • Osaka
      • Suita, Osaka, Japan, 565-0871
    • Shiga
      • Otsu, Shiga, Japan, 520-2192
    • Tochigi
      • Shimotsuke, Tochigi, Japan, 329-0498

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: VTE 2Q4 first, then VTE 2Q8
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)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adverse Event collection
Time Frame: Week 52
Week 52

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Collaborators

Regeneron Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (ACTUAL)

September 1, 2013

Study Completion (ACTUAL)

September 1, 2013

Study Registration Dates

First Submitted

January 16, 2012

First Submitted That Met QC Criteria

January 16, 2012

First Posted (ESTIMATE)

January 20, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

October 9, 2014

Last Update Submitted That Met QC Criteria

October 8, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15657 (Other Identifier: Other)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Macular Edema

Clinical Trials on VEGF Trap-Eye (BAY86-5321)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Australia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe