VEGF Trap-Eye in Vision Impairment Due to DME (VIVID-DME)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01331681
First received: April 7, 2011
Last updated: May 28, 2014
Last verified: May 2014
  Purpose

To determine the efficacy of intravitreally (IVT) administered VEGF Trap-Eye on the best-corrected visual acuity (BCVA) assessed by the early treatment diabetic retinopathy study (ETDRS) chart in subjects with diabetic macular edema (DME) with central involvement


Condition Intervention Phase
Diabetes Mellitus
Macular Edema
Biological: VEGF Trap-Eye (BAY86-5321)
Procedure: Laser treatment
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double Masked, Active Controlled, Phase III Study of the Efficacy and Safety of Repeated Doses of Intravitreal VEGF Trap-Eye in Subjects With Diabetic Macular Edema

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Change from baseline of BCVA in ETDRS letter score [ Time Frame: Week 52 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change in retinal thickness from baseline [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
  • Change in quality of life questionnaire subscale 1 from Baseline [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
  • Change in quality of life questionnaire subscale 2 from Baseline [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
  • Proportion of subjects who gain threshold 1 change from baseline in visual acuity [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
  • Proportion of subjects who gain threshold 2 change from baseline in visual acuity [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
  • Proportion of subjects who gain a threshold change from baseline in the diabetic retinopathy severity score [ Time Frame: Week 52 ] [ Designated as safety issue: No ]

Enrollment: 404
Study Start Date: May 2011
Estimated Study Completion Date: April 2015
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Biological: VEGF Trap-Eye (BAY86-5321)
VEGF Trap-Eye Regimen 1
Experimental: Arm 2 Biological: VEGF Trap-Eye (BAY86-5321)
VEGF Trap-Eye Regimen 2
Active Comparator: Arm 3 Procedure: Laser treatment
Macular laser photocoagulation using modified ETDRS protocol

  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 secondary to diabetes mellitus involving the center of the macula in the study eye
  • Decrease in vision determined to be primarily the result of DME in the study eye
  • BCVA ETDRS letter score of 73 to 24 (20/40 to 20/320) in the study eye

Exclusion Criteria:

  • Laser photocoagulation (panretinal or macular) in the study eye within 90 days of Day 1
  • More than 2 previous macular laser treatments in the study eye
  • Previous use of intraocular or periocular corticosteroids in the study eye within 120 days of Day 1
  • Previous treatment with antiangiogenic drugs in either eye (pegaptanib sodium, bevacizumab, ranibizumab etc.) within 90 days of Day 1
  • Active proliferative diabetic retinopathie (PDR) in the study eye, with the exception of inactive, regressed PDR
  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01331681

  Hide Study Locations
Locations
Australia, New South Wales
Chatswood, New South Wales, Australia, 2067
Sydney, New South Wales, Australia, 2000
Westmead, New South Wales, Australia, 2145
Australia, Victoria
East Melbourne, Victoria, Australia, 3002
Prahran, Victoria, Australia
Australia, Western Australia
Nedlands, Western Australia, Australia, 6009
Australia
Parramatta, Australia, 2150
Austria
Linz, Oberösterreich, Austria, 4020
Linz, Austria, 4021
Wien, Austria, 1090
Czech Republic
Hradec Kralove, Czech Republic, 500 05
Olomouc, Czech Republic, 77520
Ostrava, Czech Republic, 708 52
Praha 10, Czech Republic, 100 34
Zlin, Czech Republic, 760 01
Denmark
Glostrup, Denmark, 2600
Odense C, Denmark, 5000
Århus C, Denmark, 8000
France
Bordeaux, France, 33000
Creteil Cedex, France, 94010
Lyon, France, 69003
Marseille, France, 13008
Nantes Cedex, France, 44035
Paris, France, 75010
Paris, France, 75015
Paris, France, 75006
Germany
Freiburg, Baden-Württemberg, Germany, 79106
Heidelberg, Baden-Württemberg, Germany, 69120
Mannheim, Baden-Württemberg, Germany, 68167
Tübingen, Baden-Württemberg, Germany, 72076
München, Bayern, Germany, 81675
Darmstadt, Hessen, Germany, 64297
Göttingen, Niedersachsen, Germany, 37075
Aachen, Nordrhein-Westfalen, Germany, 52074
Bochum, Nordrhein-Westfalen, Germany, 44892
Bonn, Nordrhein-Westfalen, Germany, 53105
Köln, Nordrhein-Westfalen, Germany, 50924
Münster, Nordrhein-Westfalen, Germany, 48145
Ludwigshafen, Rheinland-Pfalz, Germany, 67063
Mainz, Rheinland-Pfalz, Germany, 55131
Chemnitz, Sachsen, Germany, 09116
Dresden, Sachsen, Germany, 06067
Leipzig, Sachsen, Germany, 04103
Kiel, Schleswig-Holstein, Germany, 24105
Berlin, Germany, 12200
Hungary
Budapest, Hungary, 1106
Budapest, Hungary, 1133
Budapest, Hungary, 1083
Debrecen, Hungary, 4032
Veszprem, Hungary, 8200
Zalaegerszeg, Hungary, H-8900
Italy
Ancona, Italy, 60126
Milano, Italy, 20157
Milano, Italy, 20122
Padova, Italy, 35128
Roma, Italy, 00133
Roma, Italy, 00198
Japan
Nagoya, Aichi, Japan, 467-8602
Nagoya, Aichi, Japan, 466-8560
Asahikwa, Hokkaido, Japan, 078-8510
Sapporo, Hokkaido, Japan, 060-8648
Kawasaki, Kanagawa, Japan, 216-8511
Sendai, Miyagi, Japan, 980-8574
Matsumoto, Nagano, Japan, 390-8621
Yufu, Oita, Japan, 879-5593
Hirakata, Osaka, Japan, 573-1191
Chiyoda-ku, Tokyo, Japan, 101-8309
Itabashi-ku, Tokyo, Japan, 173-8606
Mitaka, Tokyo, Japan, 181-8611
Shinjuku-ku, Tokyo, Japan, 162-8666
Akita, Japan, 010-8543
Chiba, Japan, 260-8677
Fukuoka, Japan, 812-8582
Nagasaki, Japan, 852-8501
Osaka, Japan, 545-8586
Wakayama, Japan, 641-8510
Poland
Bialystok, Poland, 15-276
Bytom, Poland, 41-902
Wroclaw, Poland, 51-124
Wroclaw, Poland, 50-368
Spain
Santiago de Compostela, A Coruña, Spain, 15705
Oviedo, Asturias, Spain, 33012
Sant Cugat del V., Barcelona, Spain, 08190
Alicante, Spain, 03016
Barcelona, Spain, 08036
Pamplona, Spain, 31008
Valencia, Spain, 46015
Taiwan
Changhua City, Changhua, Taiwan, 500
Kaohsiung, Taiwan, 81362
Taipei, Taiwan
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: NCT01331681     History of Changes
Other Study ID Numbers: 91745, 2010-022364-12
Study First Received: April 7, 2011
Last Updated: May 28, 2014
Health Authority: Austria: Agency for Health and Food Safety
Australia: Department of Health and Ageing Therapeutic Goods Administration
Germany: Federal Institute for Drugs and Medical Devices
Japan: Pharmaceuticals and Medical Devices Agency
Italy: The Italian Medicines Agency
Spain: Spanish Agency of Medicines
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Czech Republic: State Institute for Drug Control
Denmark: Danish Medicines Agency
Hungary: National Institute of Pharmacy
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

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

Additional relevant MeSH terms:
Diabetes Mellitus
Edema
Macular Edema
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on July 31, 2014