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

This study has been completed.
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01512966
First received: January 16, 2012
Last updated: September 9, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Macular Edema
Biological: VEGF Trap-Eye (BAY86-5321)
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Adverse Event collection [ Time Frame: Week 52 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change from baseline in BCVA (best corrected visual acuity) letter score [ Time Frame: Week 52 ] [ Designated as safety issue: No ]

Enrollment: 73
Study Start Date: January 2012
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01512966

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

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01512966     History of Changes
Other Study ID Numbers: 15657
Study First Received: January 16, 2012
Last Updated: September 9, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Bayer:
Diabetic Macular Edema
DME
VEGF Trap-Eye
best-corrected visual acuity (BCVA)

Additional relevant MeSH terms:
Edema
Macular Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on April 16, 2014