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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:
Bayer
ClinicalTrials.gov Identifier:
NCT01331681
First received: April 7, 2011
Last updated: March 8, 2013
Last verified: March 2013
History of Changes
  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:

MedlinePlus related topics: Diabetes Edema
Drug Information available for: Aflibercept
U.S. FDA Resources

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 ]
  • Proportion of subjects who gain a threshold change from baseline in visual acuity [ 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 ]

Enrollment: 404
Study Start Date: May 2011
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: May 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01331681

  Show 90 Study Locations
Sponsors and Collaborators
Bayer
Regeneron Pharmaceuticals
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Therapeutic Area Head, Bayer Healthcare AG
ClinicalTrials.gov Identifier: NCT01331681     History of Changes
Other Study ID Numbers: 91745, 2010-022364-12
Study First Received: April 7, 2011
Last Updated: March 8, 2013
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 May 16, 2013