Back to resultsJapanese Safety Study of VEGF Trap-Eye in DME (Diabetic Macular Edema) (VIVID-Japan)
Primary Purpose
Macular Edema
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
VEGF Trap-Eye (BAY86-5321)
Sponsored by
About this trial
This is an interventional treatment trial for Macular Edema focused on measuring Diabetic Macular Edema, DME, VEGF Trap-Eye, best-corrected visual acuity (BCVA)
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
VTE 2Q4 first, then VTE 2Q8
Arm 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)
Outcomes
Primary Outcome Measures
Adverse Event collection
Secondary Outcome Measures
Change from baseline in BCVA (best corrected visual acuity) letter score
Full Information
NCT ID
NCT01512966
First Posted
January 16, 2012
Last Updated
October 8, 2014
Sponsor
Bayer
Collaborators
Regeneron Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT01512966
Brief Title
Japanese Safety Study of VEGF Trap-Eye in DME (Diabetic Macular Edema)
Acronym
VIVID-Japan
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
Collaborators
Regeneron Pharmaceuticals
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Edema
Keywords
Diabetic Macular Edema, DME, VEGF Trap-Eye, best-corrected visual acuity (BCVA)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
73 (Actual)
8. Arms, Groups, and Interventions
Arm Title
VTE 2Q4 first, then VTE 2Q8
Arm Type
Experimental
Arm 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)
Intervention Type
Biological
Intervention Name(s)
VEGF Trap-Eye (BAY86-5321)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Adverse Event collection
Time Frame
Week 52
Secondary Outcome Measure Information:
Title
Change from baseline in BCVA (best corrected visual acuity) letter score
Time Frame
Week 52
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Matsuyama
State/Province
Ehime
ZIP/Postal Code
790-8524
Country
Japan
City
Maebashi
State/Province
Gunma
ZIP/Postal Code
371-8511
Country
Japan
City
Kobe
State/Province
Hyogo
ZIP/Postal Code
650-0017
Country
Japan
City
Mito
State/Province
Ibaraki
ZIP/Postal Code
310-0015
Country
Japan
City
Kita
State/Province
Kagawa
ZIP/Postal Code
761-0793
Country
Japan
City
Kawasaki
State/Province
Kanagawa
ZIP/Postal Code
216-8511
Country
Japan
City
Sendai
State/Province
Miyagi
ZIP/Postal Code
984-8560
Country
Japan
City
Kashihara
State/Province
Nara
ZIP/Postal Code
634-8522
Country
Japan
City
Suita
State/Province
Osaka
ZIP/Postal Code
565-0871
Country
Japan
City
Otsu
State/Province
Shiga
ZIP/Postal Code
520-2192
Country
Japan
City
Shimotsuke
State/Province
Tochigi
ZIP/Postal Code
329-0498
Country
Japan
City
Kagoshima
ZIP/Postal Code
890-8520
Country
Japan
City
Kyoto
ZIP/Postal Code
606-8507
Country
Japan
City
Okayama
ZIP/Postal Code
700-8558
Country
Japan
City
Osaka
ZIP/Postal Code
537-0025
Country
Japan
City
Osaka
ZIP/Postal Code
558-8558
Country
Japan
City
Saga
ZIP/Postal Code
840-8571
Country
Japan
City
Wakayama
ZIP/Postal Code
641-8510
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Japanese Safety Study of VEGF Trap-Eye in DME (Diabetic Macular Edema)
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