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

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ClinicalTrials.gov Identifier: NCT01512966
Recruitment Status : Completed
First Posted : January 20, 2012
Last Update Posted : October 9, 2014
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Bayer

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.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 73 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : January 2012
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema
U.S. FDA Resources

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.



Primary Outcome Measures :
  1. Adverse Event collection [ Time Frame: Week 52 ]

Secondary Outcome Measures :
  1. Change from baseline in BCVA (best corrected visual acuity) letter score [ Time Frame: Week 52 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01512966     History of Changes
Other Study ID Numbers: 15657
First Posted: January 20, 2012    Key Record Dates
Last Update Posted: October 9, 2014
Last Verified: October 2014

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